Apertus Partners
Madison, New Jersey, United States
Apertus Partners is seeking a Program Manager for clinical development in Madison, NJ. Description: The Senior Manager, Clinical Development may have global or regional responsibilities and is expected to fulfill the Clinical Scientist (CS) role within the Gastroenterology Therapeutic Area: The CS is responsible and accountable for the scientific/clinical implementation of the Clinical Development Plan at the Clinical Trial Team level. The CS supports the Clinical Program Lead (CPL) and Clinical Science Lead (CSL) in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy. The CS is the key Clinical Development contact for the Clinical Trial Team and is responsible for: - Representing Clinical Development as a core team member on the Clinical Trial Team - Providing a clinical review of study-specific documentation and training materials - Performing clinical data reviews - Assessing reported protocol deviations - Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Trial Team The CS may present the clinical development aspects of a project and clinical trial results at internal meetings. The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures. Note: While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a particular job and to assign other duties as necessary and at any time. Minimum Requirements - Relevant science degree (e.g., MD, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area preferred - At least 6 years of overall work experience - At least 4 years of clinical/research experience in the pharmaceutical/device industry - Ability to travel up to at least 10% of time, including international travel Essential Skills & Abilities: Teamwork: - Understands cross-functional roles & responsibilities to effectively & efficiently accomplish team goals - Takes initiative to contribute clinically relevant scientific ideas and knowledge to team globally - Participates in team activities - Actively listens - Understands and leverages cross-functional roles and responsibilities - Ability to adapt to change in project and team strategy Influential Communication: - Uses facts and data to validate own position - Influences through reason - Actively seeks to understand other perspectives - Articulates business impact - Matches communication to audience - Ability to build consensus - Communicates effectively with internal/external stakeholders - Encourages ideas from others - Ability to explain complex issues - Actively influences others without a direct reporting relationship Strategic Thinking: - Ability to make connections between organization, team, product, ideas, etc. - Ability to understand implications of strategic decisions - Seeks more knowledge of industry, competitors - Welcomes change - Encourages innovation and efficiency Execution and Accountability: - Identifies and resolves complex problems - Delegates to team and keeps them focused, as applicable - Identifies and implements best practices - Identifies and drives priorities - Takes charge of removing obstacles to project as appropriate with the team - Ability to work on and communicate solutions, even in the case of unpopular business needs - Meets corporate timelines Global Mind Set: - Demonstrates basic understanding of global pharmaceutical/ device product development environment - Builds relationships with global colleagues - Demonstrates understanding and respect for cultural differences and needs - Inclusive in interaction with others - Embraces diversity of thoughts, ideas, and approaches
Mar 08, 2019
Contractor
Apertus Partners is seeking a Program Manager for clinical development in Madison, NJ. Description: The Senior Manager, Clinical Development may have global or regional responsibilities and is expected to fulfill the Clinical Scientist (CS) role within the Gastroenterology Therapeutic Area: The CS is responsible and accountable for the scientific/clinical implementation of the Clinical Development Plan at the Clinical Trial Team level. The CS supports the Clinical Program Lead (CPL) and Clinical Science Lead (CSL) in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy. The CS is the key Clinical Development contact for the Clinical Trial Team and is responsible for: - Representing Clinical Development as a core team member on the Clinical Trial Team - Providing a clinical review of study-specific documentation and training materials - Performing clinical data reviews - Assessing reported protocol deviations - Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Trial Team The CS may present the clinical development aspects of a project and clinical trial results at internal meetings. The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures. Note: While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a particular job and to assign other duties as necessary and at any time. Minimum Requirements - Relevant science degree (e.g., MD, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area preferred - At least 6 years of overall work experience - At least 4 years of clinical/research experience in the pharmaceutical/device industry - Ability to travel up to at least 10% of time, including international travel Essential Skills & Abilities: Teamwork: - Understands cross-functional roles & responsibilities to effectively & efficiently accomplish team goals - Takes initiative to contribute clinically relevant scientific ideas and knowledge to team globally - Participates in team activities - Actively listens - Understands and leverages cross-functional roles and responsibilities - Ability to adapt to change in project and team strategy Influential Communication: - Uses facts and data to validate own position - Influences through reason - Actively seeks to understand other perspectives - Articulates business impact - Matches communication to audience - Ability to build consensus - Communicates effectively with internal/external stakeholders - Encourages ideas from others - Ability to explain complex issues - Actively influences others without a direct reporting relationship Strategic Thinking: - Ability to make connections between organization, team, product, ideas, etc. - Ability to understand implications of strategic decisions - Seeks more knowledge of industry, competitors - Welcomes change - Encourages innovation and efficiency Execution and Accountability: - Identifies and resolves complex problems - Delegates to team and keeps them focused, as applicable - Identifies and implements best practices - Identifies and drives priorities - Takes charge of removing obstacles to project as appropriate with the team - Ability to work on and communicate solutions, even in the case of unpopular business needs - Meets corporate timelines Global Mind Set: - Demonstrates basic understanding of global pharmaceutical/ device product development environment - Builds relationships with global colleagues - Demonstrates understanding and respect for cultural differences and needs - Inclusive in interaction with others - Embraces diversity of thoughts, ideas, and approaches
Apertus Partners
Madison, New Jersey, United States
Apertus Partners is seeking a Medical Director in Madison, NJ. Description: Summary: Under administrative direction, provides medical expertise to assist with clinical product development in the Company's specific therapeutic focus areas. The Medical Monitor will serve as the medical expert for assigned clinical trials. This role will provide input into the design and conduct of clinical trials, assessment and interpretation of safety data, and contribute to investigator training. Available as a remote position from a home-based office. Essential Duties and Responsibilities* - Working with program leadership and team members to further clinical development program by assisting in the design and conduct of clinical trials including the drafting of protocols and amendments and contributing to related clinical documents. - Be the Medical Expert ("Medical Monitor") for assigned clinical trials which includes being readily available to advise on trial-related medical questions or problems during the conduct of the trial. - Lead medical aspects of medical monitoring, including CRO oversight for medical monitoring activities as needed - Identifies study challenges during the conduct of the study and works with relevant stakeholders to ascertain and implement solutions - Contribute to investigator training. - Contribute to responses regarding IRB/ethics committee queries - Assist in medical data review, assessment and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation. - Work closely with the other departments providing medical input into safety reports including, SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, Company Core Safety Information (CCSI), Investigator Brochure (IB), Risk Management Plans, Integrated Summaries of Safety and Efficacy, Clinical Study Reports and preparation of labels. - Collaborate with safety/pharmacovigilance to implement the safety monitoring plan - Attendance at teleconferences and face-to-face meetings for study activities as needed. - Responsible for implementing alignment across policies/procedures and ensure that data generated meet monitoring and compliance with FDA, ICH guidelines and GCP. - Works with team members in a matrix environment with the ability to work on multiple, complex projects in parallel *additional duties and responsibilities not listed here may be required Qualifications (Education & Experience) - Medical degree with strong leadership skills including 5-10 years direct experience in the pharmaceutical industry preferably in a medical monitoring role. - US and EU experience preferred. - Experience in IBD preferred but all therapeutic areas will be considered. - Understanding of local and global drug safety regulations and processes and clinical trial oversight, including global GCPs. - Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders. - Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing. - Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities Minimum Qualifications: Medical degree (M.D.) in a scientific/technical or related field from an accredited college or university, and six (6) years pharmaceutical/clinical experience, including four (4) years in a supervisory or management capacity or an equivalent combination of education and experience.
Mar 08, 2019
Contractor
Apertus Partners is seeking a Medical Director in Madison, NJ. Description: Summary: Under administrative direction, provides medical expertise to assist with clinical product development in the Company's specific therapeutic focus areas. The Medical Monitor will serve as the medical expert for assigned clinical trials. This role will provide input into the design and conduct of clinical trials, assessment and interpretation of safety data, and contribute to investigator training. Available as a remote position from a home-based office. Essential Duties and Responsibilities* - Working with program leadership and team members to further clinical development program by assisting in the design and conduct of clinical trials including the drafting of protocols and amendments and contributing to related clinical documents. - Be the Medical Expert ("Medical Monitor") for assigned clinical trials which includes being readily available to advise on trial-related medical questions or problems during the conduct of the trial. - Lead medical aspects of medical monitoring, including CRO oversight for medical monitoring activities as needed - Identifies study challenges during the conduct of the study and works with relevant stakeholders to ascertain and implement solutions - Contribute to investigator training. - Contribute to responses regarding IRB/ethics committee queries - Assist in medical data review, assessment and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation. - Work closely with the other departments providing medical input into safety reports including, SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, Company Core Safety Information (CCSI), Investigator Brochure (IB), Risk Management Plans, Integrated Summaries of Safety and Efficacy, Clinical Study Reports and preparation of labels. - Collaborate with safety/pharmacovigilance to implement the safety monitoring plan - Attendance at teleconferences and face-to-face meetings for study activities as needed. - Responsible for implementing alignment across policies/procedures and ensure that data generated meet monitoring and compliance with FDA, ICH guidelines and GCP. - Works with team members in a matrix environment with the ability to work on multiple, complex projects in parallel *additional duties and responsibilities not listed here may be required Qualifications (Education & Experience) - Medical degree with strong leadership skills including 5-10 years direct experience in the pharmaceutical industry preferably in a medical monitoring role. - US and EU experience preferred. - Experience in IBD preferred but all therapeutic areas will be considered. - Understanding of local and global drug safety regulations and processes and clinical trial oversight, including global GCPs. - Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders. - Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing. - Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities Minimum Qualifications: Medical degree (M.D.) in a scientific/technical or related field from an accredited college or university, and six (6) years pharmaceutical/clinical experience, including four (4) years in a supervisory or management capacity or an equivalent combination of education and experience.
Apertus Partners
Madison, New Jersey, United States
Apertus Partners is seeking a program manager for clinical development in Madison, NJ. Description: The Program Manager, Clinical Development may have global or regional responsibilities and is expected to fulfil the Clinical Scientist (CS) role within the Gastroenterology Therapeutic Area: The CS is responsible and accountable for the scientific/clinical implementation of the Clinical Development Plan at the Clinical Trial Team level. The CS supports the Clinical Program Lead (CPL) and Clinical Science Lead (CSL) in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy. The CS is the key Clinical Development contact for the Clinical Trial Team and is responsible for: - Representing Clinical Development as a core team member on the Clinical Trial Team - Providing a clinical review of study-specific documentation and training materials - Performing clinical data reviews - Assessing reported protocol deviations - Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Trial Team The CS may present the clinical development aspects of a project and clinical trial results at internal meetings. The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures. Note: While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a particular job and to assign other duties as necessary and at any time. Minimum Requirements - Relevant science degree (e.g., MD, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area preferred - At least 6 years of overall work experience - At least 4 years of clinical/research experience in the pharmaceutical/device industry - Ability to travel up to at least 10% of time, including international travel Essential Skills & Abilities: Teamwork: - Understands cross-functional roles & responsibilities to effectively & efficiently accomplish team goals - Takes initiative to contribute clinically relevant scientific ideas and knowledge to team globally - Participates in team activities - Actively listens - Understands and leverages cross-functional roles and responsibilities - Ability to adapt to change in project and team strategy Influential Communication: - Uses facts and data to validate own position - Influences through reason - Actively seeks to understand other perspectives - Articulates business impact - Matches communication to audience - Ability to build consensus - Communicates effectively with internal/external stakeholders - Encourages ideas from others - Ability to explain complex issues - Actively influences others without a direct reporting relationship Strategic Thinking: - Ability to make connections between organization, team, product, ideas, etc. - Ability to understand implications of strategic decisions - Seeks more knowledge of industry, competitors - Welcomes change - Encourages innovation and efficiency Execution and Accountability: - Identifies and resolves complex problems - Delegates to team and keeps them focused, as applicable - Identifies and implements best practices - Identifies and drives priorities - Takes charge of removing obstacles to project as appropriate with the team - Ability to work on and communicate solutions, even in the case of unpopular business needs - Meets corporate timelines Global Mind Set: - Demonstrates basic understanding of global pharmaceutical/ device product development environment - Builds relationships with global colleagues - Demonstrates understanding and respect for cultural differences and needs - Inclusive in interaction with others - Embraces diversity of thoughts, ideas, and approaches
Mar 08, 2019
Contractor
Apertus Partners is seeking a program manager for clinical development in Madison, NJ. Description: The Program Manager, Clinical Development may have global or regional responsibilities and is expected to fulfil the Clinical Scientist (CS) role within the Gastroenterology Therapeutic Area: The CS is responsible and accountable for the scientific/clinical implementation of the Clinical Development Plan at the Clinical Trial Team level. The CS supports the Clinical Program Lead (CPL) and Clinical Science Lead (CSL) in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy. The CS is the key Clinical Development contact for the Clinical Trial Team and is responsible for: - Representing Clinical Development as a core team member on the Clinical Trial Team - Providing a clinical review of study-specific documentation and training materials - Performing clinical data reviews - Assessing reported protocol deviations - Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Trial Team The CS may present the clinical development aspects of a project and clinical trial results at internal meetings. The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures. Note: While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a particular job and to assign other duties as necessary and at any time. Minimum Requirements - Relevant science degree (e.g., MD, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area preferred - At least 6 years of overall work experience - At least 4 years of clinical/research experience in the pharmaceutical/device industry - Ability to travel up to at least 10% of time, including international travel Essential Skills & Abilities: Teamwork: - Understands cross-functional roles & responsibilities to effectively & efficiently accomplish team goals - Takes initiative to contribute clinically relevant scientific ideas and knowledge to team globally - Participates in team activities - Actively listens - Understands and leverages cross-functional roles and responsibilities - Ability to adapt to change in project and team strategy Influential Communication: - Uses facts and data to validate own position - Influences through reason - Actively seeks to understand other perspectives - Articulates business impact - Matches communication to audience - Ability to build consensus - Communicates effectively with internal/external stakeholders - Encourages ideas from others - Ability to explain complex issues - Actively influences others without a direct reporting relationship Strategic Thinking: - Ability to make connections between organization, team, product, ideas, etc. - Ability to understand implications of strategic decisions - Seeks more knowledge of industry, competitors - Welcomes change - Encourages innovation and efficiency Execution and Accountability: - Identifies and resolves complex problems - Delegates to team and keeps them focused, as applicable - Identifies and implements best practices - Identifies and drives priorities - Takes charge of removing obstacles to project as appropriate with the team - Ability to work on and communicate solutions, even in the case of unpopular business needs - Meets corporate timelines Global Mind Set: - Demonstrates basic understanding of global pharmaceutical/ device product development environment - Builds relationships with global colleagues - Demonstrates understanding and respect for cultural differences and needs - Inclusive in interaction with others - Embraces diversity of thoughts, ideas, and approaches
Apertus Partners
Irvine, CA, Irvine, California, United States
Apertus Partners is seeking a Sr. Associate, Clinical Trial Management in Irvine, CA. Description Position Summary: - supports CTM/OSL in ensuring the assigned clinical study(ies) are run on time and to budget and are completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures Tasks: Assist CTM/OSL with: - regional site feasibility, when necessary - tracking of site training, certification, delivery of ancillary supplies, etc. necessary for site activation - development of study-specific documents, when necessary - regional vendor management: manage vendor issues, coordinate contract amendments, create monthly vendor accruals, process and track monthly invoices, provide quarterly budget forecast assumptions - periodic review of protocol deviations - database lock activities (interim or final lock) - regional study drug management: track shipping or storage site temperature excursions - regional trial master file management (TMF): ensure all documents are appropriately filed in the TMF - regional enrollment management: site activation and enrollment tracking for monthly reporting Experience: - 3+ years relevant experience at pharmaceutical CRO or sponsor - Experience supporting clinical trials - Handle and prioritize multiple tasks simultaneously - Work effectively in a team/matrix environment - Understand technical, scientific and medical information - Handle conflict management and resolution - Familiarity with clinical study budgets and accruals Knowledge: Candidate must have a good understanding of the following: - Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based) - Knowledge of concepts of clinical research and drug development - Prefer but not a must have - Ophthalmology area experience Qualifications: - Bachelor's degree or higher - Science degree preferably in science or health-related field - Previous experience of working on a clinical study Other: - Position is Irvine, CA based but may have option to work from home 2 days per week
Mar 06, 2019
Contractor
Apertus Partners is seeking a Sr. Associate, Clinical Trial Management in Irvine, CA. Description Position Summary: - supports CTM/OSL in ensuring the assigned clinical study(ies) are run on time and to budget and are completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures Tasks: Assist CTM/OSL with: - regional site feasibility, when necessary - tracking of site training, certification, delivery of ancillary supplies, etc. necessary for site activation - development of study-specific documents, when necessary - regional vendor management: manage vendor issues, coordinate contract amendments, create monthly vendor accruals, process and track monthly invoices, provide quarterly budget forecast assumptions - periodic review of protocol deviations - database lock activities (interim or final lock) - regional study drug management: track shipping or storage site temperature excursions - regional trial master file management (TMF): ensure all documents are appropriately filed in the TMF - regional enrollment management: site activation and enrollment tracking for monthly reporting Experience: - 3+ years relevant experience at pharmaceutical CRO or sponsor - Experience supporting clinical trials - Handle and prioritize multiple tasks simultaneously - Work effectively in a team/matrix environment - Understand technical, scientific and medical information - Handle conflict management and resolution - Familiarity with clinical study budgets and accruals Knowledge: Candidate must have a good understanding of the following: - Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based) - Knowledge of concepts of clinical research and drug development - Prefer but not a must have - Ophthalmology area experience Qualifications: - Bachelor's degree or higher - Science degree preferably in science or health-related field - Previous experience of working on a clinical study Other: - Position is Irvine, CA based but may have option to work from home 2 days per week
Apertus Partners
Bridgewater, NJ, Bridgewater, New Jersey, United States
Apertus Partners is seeking an R&D Technician in Bridgewater, NJ. Description: Summary: Under close supervision, performs routine lab supporting in glassware cleaning, dissolution bath cleaning, dissolution media preparation, disposition of expired chemicals and reagents, handling lab wastes. Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks. - Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. - Learns to perform lab glassware and in accordance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). - Learns to perform dissolution bath and in accordance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). - Learns to perform dissolution media preparation and in accordance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). - Learns to dispose of acid waste and organic solvent waste according to Environmental Protection Agency (EPA) regulations, and transfers gas cylinders as instructed by management. - Learns to handle lab wastes generated from HPLC, washing machine etc. and in accordance with Standard Operating Procedures (SOPs) and according to Environmental Protection Agency (EPA) regulations. - Perform lab housekeeping practices. - Ensures compliance with all Company policies and procedures, including safety rules and regulations. Knowledge of: - Current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements. - Basic chemistry laboratory practices and techniques. - Personal computer hardware and software applications. - Business English usage, spelling, grammar and punctuation. - Basic mathematical computations. - Current Company policies, practices and procedures, including safety rules and regulations. Skill in: - Following verbal and written directions. - Communicating clearly and concisely, both orally and in writing. - Operating scientific and personal computers. - Establishing and maintaining cooperative working relationships with others. - Ensuring compliance with all Company policies and procedures, including safety rules and regulations. Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of sitting, standing, walking, lifting materials weighing up to 50 pounds, vision to monitor and moderate to loud noise levels. Incumbents may be exposed to or work with toxic materials, toxic gases, electrical hazards, dangerous tools and equipment. Work is performed in laboratory environments. Minimum Qualifications: High School Diploma or equivalent, with minimum of Three (3) year related experience in pharmaceutical manufacturing laboratory; or an equivalent combination of education and experience.
Mar 06, 2019
Contractor
Apertus Partners is seeking an R&D Technician in Bridgewater, NJ. Description: Summary: Under close supervision, performs routine lab supporting in glassware cleaning, dissolution bath cleaning, dissolution media preparation, disposition of expired chemicals and reagents, handling lab wastes. Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks. - Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. - Learns to perform lab glassware and in accordance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). - Learns to perform dissolution bath and in accordance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). - Learns to perform dissolution media preparation and in accordance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). - Learns to dispose of acid waste and organic solvent waste according to Environmental Protection Agency (EPA) regulations, and transfers gas cylinders as instructed by management. - Learns to handle lab wastes generated from HPLC, washing machine etc. and in accordance with Standard Operating Procedures (SOPs) and according to Environmental Protection Agency (EPA) regulations. - Perform lab housekeeping practices. - Ensures compliance with all Company policies and procedures, including safety rules and regulations. Knowledge of: - Current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements. - Basic chemistry laboratory practices and techniques. - Personal computer hardware and software applications. - Business English usage, spelling, grammar and punctuation. - Basic mathematical computations. - Current Company policies, practices and procedures, including safety rules and regulations. Skill in: - Following verbal and written directions. - Communicating clearly and concisely, both orally and in writing. - Operating scientific and personal computers. - Establishing and maintaining cooperative working relationships with others. - Ensuring compliance with all Company policies and procedures, including safety rules and regulations. Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of sitting, standing, walking, lifting materials weighing up to 50 pounds, vision to monitor and moderate to loud noise levels. Incumbents may be exposed to or work with toxic materials, toxic gases, electrical hazards, dangerous tools and equipment. Work is performed in laboratory environments. Minimum Qualifications: High School Diploma or equivalent, with minimum of Three (3) year related experience in pharmaceutical manufacturing laboratory; or an equivalent combination of education and experience.
Apertus Partners
Irvine, California, United States
Apertus Partners is seeking a Clinical Trial Assistant in Irvine, CA. Description I. ROLE SUMMARY: Responsible for supporting the Clinical Trial Management/operational study team to manage the various aspects of the operational execution and delivery of quality studies, including in process quality control activities. PRIMARY JOB RESPONSIBILITIES Primary responsibilities of this position include: - Supports the Clinical Trial Management/operational study teams in the execution and delivery of studies - Support study feasibility activities and perform database/web searches for sites as needed. Work closely with the Site Start Up (SSU) and ensure all study related regulatory and financial documents are collected and reviewed in support of study activation. - Organize and maintain project working files and track critical documents. Report discrepancies to the appropriate clinical team member in a timely manner. - Reconcile and transmit all essential documentation to CDIC as per Forest policy. - Track and assist with processing site/vendor payments. Follow up on any issues as required. - Collect and track patient enrollment information and update study management reports as necessary. - Participate in testing of specifications and edit checks for internal (i.e. electronic data capture (EDC) and external (e.g. Interactive Voice/Web Response Systems (IVRS/IWRS), laboratory vendors) systems. - Assist senior team members with in the planning, preparation, and on-site support of investigators meetings. - Generate reports in various applications to assist the Clinical Trial Managers to perform clinical data review. - Assist with the preparation and distribution of meeting agendas and minutes. Actively participate in team meetings. - Support the Regional Site Managers by providing study related information and supplies, as requested. - Communicate with IRBs and outside vendors to provide information and/or resolution to specific requests/issues. - Support and correspond with sites to identify site specific needs (e.g. order and track study drug/other trial related supplies). Additional Responsibilities: - Contribute to process improvement efforts including task forces and committees. - Support clinical team with requests from management as needed. - May deliver training related to day-to-day responsibilities for new CTA and CTM hires within department. - May provide administrative support to manager/group as assigned. - Manage calendars and appointments. Resolve scheduling conflicts as needed. - Manage and coordinate travel requirements for group, consultants, and partners. - Prepare and oversee expense account reporting. May contribute to tracking budgets as needed. - Support document filing and organizing as needed. - Schedule and coordinate new hire candidate interviews. - Coordinate and process office supply orders. - Function as a back up to general Clinical Trial Manager activities as needed. CSR Development and Reporting: - Responsible for providing operation support into the CSR III. JOB QUALIFICATIONS Education: - Associate degree or higher preferred Experience: - 1-2 year relevant experience in pharmaceutical industry or CRO - Experience supporting clinical trials preferred Licensure/Credentials: N/A Knowledge, Skills, and Abilities: - Basic knowledge of drug development and FDA GCP/ICH regulatory guidelines is a plus - Proficiency with Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat - Strong skills with Microsoft Excel required - Experience using electronic data capture (EDC) systems is a plus - Must possess excellent skill/ability in the following: - Oral and Written Communication - Organizing - Judgment and Problem Solving - People Relationships - Initiative and Accountability - Ability to manage multiple tasks IV. PHYSICAL REQUIREMENTS The requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Refer to the Position Description - Office Position - with minimal travel ( up to 5%) V. SCOPE OF POSITION Supervision Received: Supervised by Clinical Trial Manager, Clinical Operations; Mentored by, and receives direction for specific study activities from Clinical Trial Manager Supervision Exercised: NA VI. PRINCIPAL CONTACTS Internal: - Clinical Document and Information Center (CDIC) - Contracts Management - Site Start Up - Study team members - Informatics External: - Sites - Vendors - IRB
Mar 01, 2019
Contractor
Apertus Partners is seeking a Clinical Trial Assistant in Irvine, CA. Description I. ROLE SUMMARY: Responsible for supporting the Clinical Trial Management/operational study team to manage the various aspects of the operational execution and delivery of quality studies, including in process quality control activities. PRIMARY JOB RESPONSIBILITIES Primary responsibilities of this position include: - Supports the Clinical Trial Management/operational study teams in the execution and delivery of studies - Support study feasibility activities and perform database/web searches for sites as needed. Work closely with the Site Start Up (SSU) and ensure all study related regulatory and financial documents are collected and reviewed in support of study activation. - Organize and maintain project working files and track critical documents. Report discrepancies to the appropriate clinical team member in a timely manner. - Reconcile and transmit all essential documentation to CDIC as per Forest policy. - Track and assist with processing site/vendor payments. Follow up on any issues as required. - Collect and track patient enrollment information and update study management reports as necessary. - Participate in testing of specifications and edit checks for internal (i.e. electronic data capture (EDC) and external (e.g. Interactive Voice/Web Response Systems (IVRS/IWRS), laboratory vendors) systems. - Assist senior team members with in the planning, preparation, and on-site support of investigators meetings. - Generate reports in various applications to assist the Clinical Trial Managers to perform clinical data review. - Assist with the preparation and distribution of meeting agendas and minutes. Actively participate in team meetings. - Support the Regional Site Managers by providing study related information and supplies, as requested. - Communicate with IRBs and outside vendors to provide information and/or resolution to specific requests/issues. - Support and correspond with sites to identify site specific needs (e.g. order and track study drug/other trial related supplies). Additional Responsibilities: - Contribute to process improvement efforts including task forces and committees. - Support clinical team with requests from management as needed. - May deliver training related to day-to-day responsibilities for new CTA and CTM hires within department. - May provide administrative support to manager/group as assigned. - Manage calendars and appointments. Resolve scheduling conflicts as needed. - Manage and coordinate travel requirements for group, consultants, and partners. - Prepare and oversee expense account reporting. May contribute to tracking budgets as needed. - Support document filing and organizing as needed. - Schedule and coordinate new hire candidate interviews. - Coordinate and process office supply orders. - Function as a back up to general Clinical Trial Manager activities as needed. CSR Development and Reporting: - Responsible for providing operation support into the CSR III. JOB QUALIFICATIONS Education: - Associate degree or higher preferred Experience: - 1-2 year relevant experience in pharmaceutical industry or CRO - Experience supporting clinical trials preferred Licensure/Credentials: N/A Knowledge, Skills, and Abilities: - Basic knowledge of drug development and FDA GCP/ICH regulatory guidelines is a plus - Proficiency with Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat - Strong skills with Microsoft Excel required - Experience using electronic data capture (EDC) systems is a plus - Must possess excellent skill/ability in the following: - Oral and Written Communication - Organizing - Judgment and Problem Solving - People Relationships - Initiative and Accountability - Ability to manage multiple tasks IV. PHYSICAL REQUIREMENTS The requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Refer to the Position Description - Office Position - with minimal travel ( up to 5%) V. SCOPE OF POSITION Supervision Received: Supervised by Clinical Trial Manager, Clinical Operations; Mentored by, and receives direction for specific study activities from Clinical Trial Manager Supervision Exercised: NA VI. PRINCIPAL CONTACTS Internal: - Clinical Document and Information Center (CDIC) - Contracts Management - Site Start Up - Study team members - Informatics External: - Sites - Vendors - IRB
Apertus Partners
Madison, New Jersey, United States
Apertus Partners is seeking an associate of clinical trial management in Madison, NJ. Description: The incumbent is responsible for performing tasks as assigned by their manager which includes but is not limited to preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and testing clinical systems, producing reports on clinical status, trends, and metrics, facilitating communication across departments, supporting the monitoring team and study sites with relevant study information, and supporting clinical operations. The incumbent ensures the assigned clinical study is run to time and budget and is completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures. The incumbent may also be asked to participate as a Global Clinical Trial Representative in cross-functional teams such as Case Report Form Review Team and Clinical Trial Team. The incumbent is responsible for all aspects of the clinical study including, but not limited, to the tasks specified below. Study Concept, Planning and Strategy Phase : The incumbent is responsible to support and work with the FACT team to conduct study feasibility. They are responsible for the initial assessment of any vendors, supplies planning and the development of study specific documents and timelines as required. Study Initiation Phase: The incumbent is responsible for supporting document development including the informed consent forms; regional investigator meetings/presentation of materials; the development of regional enrollment initiatives; and planning regional clinical study supplies. They are overall responsible in obtaining the required translations, collecting non-essential documents from site and ensuring sites are trained in collaboration with the site monitor. Study Management/Conduct Phase: The incumbent is overall responsible for supporting the following: study financial management; database lock activities; study drug management; trial master file management; study enrollment management (e.g. contingency plan execution); periodic review of protocol deviations; vendor management; and ensuring adverse event reporting. Close-Out Phase: The incumbent is overall responsible for supporting the following activities: database lock activities; ensuring all documents are filed in the TMF appropriately; ensuring all close-out activities are completed; ensuring study documentation is properly archived when the study is considered completed. The incumbent is expected to complete their assigned tasks within agreed upon project priorities, timelines and quality specifications. Other activities, special projects and assignments may be given as required. Qualifications: - Science degree preferably in science or health-related field - Previous experience working on a clinical study Experience: In addition to the essential skills, the incumbent must have the ability to: - Handle and prioritize multiple tasks simultaneously, - Work effectively in a team/matrix environment, - Understand technical, scientific and medical information, - Handle conflict management and resolution, - Understand clinical study budgets, - Plan, organise, project manage and analyse data, and - Demonstrate full competency in Microsoft Office programs. Knowledge: Employee must have a good understanding of the following: - Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based), - Knowledge of concepts of clinical research and drug development, and - General therapeutic area education and training
Feb 27, 2019
Contractor
Apertus Partners is seeking an associate of clinical trial management in Madison, NJ. Description: The incumbent is responsible for performing tasks as assigned by their manager which includes but is not limited to preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and testing clinical systems, producing reports on clinical status, trends, and metrics, facilitating communication across departments, supporting the monitoring team and study sites with relevant study information, and supporting clinical operations. The incumbent ensures the assigned clinical study is run to time and budget and is completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures. The incumbent may also be asked to participate as a Global Clinical Trial Representative in cross-functional teams such as Case Report Form Review Team and Clinical Trial Team. The incumbent is responsible for all aspects of the clinical study including, but not limited, to the tasks specified below. Study Concept, Planning and Strategy Phase : The incumbent is responsible to support and work with the FACT team to conduct study feasibility. They are responsible for the initial assessment of any vendors, supplies planning and the development of study specific documents and timelines as required. Study Initiation Phase: The incumbent is responsible for supporting document development including the informed consent forms; regional investigator meetings/presentation of materials; the development of regional enrollment initiatives; and planning regional clinical study supplies. They are overall responsible in obtaining the required translations, collecting non-essential documents from site and ensuring sites are trained in collaboration with the site monitor. Study Management/Conduct Phase: The incumbent is overall responsible for supporting the following: study financial management; database lock activities; study drug management; trial master file management; study enrollment management (e.g. contingency plan execution); periodic review of protocol deviations; vendor management; and ensuring adverse event reporting. Close-Out Phase: The incumbent is overall responsible for supporting the following activities: database lock activities; ensuring all documents are filed in the TMF appropriately; ensuring all close-out activities are completed; ensuring study documentation is properly archived when the study is considered completed. The incumbent is expected to complete their assigned tasks within agreed upon project priorities, timelines and quality specifications. Other activities, special projects and assignments may be given as required. Qualifications: - Science degree preferably in science or health-related field - Previous experience working on a clinical study Experience: In addition to the essential skills, the incumbent must have the ability to: - Handle and prioritize multiple tasks simultaneously, - Work effectively in a team/matrix environment, - Understand technical, scientific and medical information, - Handle conflict management and resolution, - Understand clinical study budgets, - Plan, organise, project manage and analyse data, and - Demonstrate full competency in Microsoft Office programs. Knowledge: Employee must have a good understanding of the following: - Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based), - Knowledge of concepts of clinical research and drug development, and - General therapeutic area education and training
Apertus Partners
Irvine, California, United States
Apertus Partners is looking to fill three (3) Senior Technical Writer positions in Irvine, CA. The ideal candidate we are looking for will site in Irvine, CA, however depending upon circumstances and candidate experience, we may welcome someone to work in Madison, NJ. Madison, New Jersey (Gastroenterology) Irvine, California (Neurology, Eye care, or Facial Aesthetics) Senior Medical Writer Scientific - Publications and Planning Responsible for assisting authors in the writing of scientific publications and effective implementation of the publications writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with multiple functional groups (eg, PK, Statistics, Health Outcomes) to ensure accurate and timely completion/delivery of publications. A Senior Medical Writer would be expected to work on publications that require in-depth product and scientific knowledge. Senior Medical writers should have a good working knowledge of biostatistics. Other activities, special projects, and assignments may be given. As a result, the percentage of time spent across roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects, and the requirements within the organization as a whole. The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Company policies, and procedures. Company policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives. Main Areas of Responsibilities: Medical Writing Writes and edits the content of scientific abstracts, posters, and manuscripts supportive of business and scientific objectives, with direction and/or guidance on medical data interpretation, publication strategy, and statistical data analysis from the PPT and external authors, as appropriate. Adhere to standardized publication processes and SOP requirements for all publishing projects. Coordinate the review, approval, submission, and production of publishing projects. General Compliance Act as subject matter expert regarding computer-based technologies utilized by the department. As assigned, maintain publication-tracking of documents, ensuring accurate, appropriate, and timely data entry. Therapeutic Area and Publishing Knowledge Learn and continually maintain therapeutic area and product knowledge and apply to publishing projects. Maintain current awareness of good publication practices and editorial policies and apply to publishing projects. Communications Communicate effectively across functional areas and within the Publishing Group to accomplish project objectives. Present information to appropriate individuals in a concise, clear, and objective manner. Requirements: - 3 years of relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D. - Ability to assimilate and interpret scientific content and translate information for appropriate audience. - Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy. - Experience in working with collaborative, cross-functional teams, including project management experience. - Knowledgeable of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. - Working knowledge of current electronic document management systems and information technology. - Excellent written and oral communication skills. - Proven ability to work independently and effectively in teams. - Organizes/reorganizes workload in accordance with project priorities and timelines with focus on execution. - Effectively demonstrate leadership and motivational skills. - Excellent planning, organization, and communication skills (written and oral). - Able to write clearly and accurately, have good analytical skills, and detail orientated. - Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment. Preferred Skills/Qualification - 3 years of experience in experimental design and clinical/preclinical data interpretation preferred. - Knowledge of biostatistics preferred. - American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical. Education - Bachelor of Science with 6-10 years' industry medical writing experience; or Bachelor's degree in English or communications with relevant science experience with 6-10 years' industry medical writing experience; or Masters of Science with 3-6 years of industry medical writing experience; or Doctoral degree with 2-4 years of industry medical writing experience.
Feb 27, 2019
Contractor
Apertus Partners is looking to fill three (3) Senior Technical Writer positions in Irvine, CA. The ideal candidate we are looking for will site in Irvine, CA, however depending upon circumstances and candidate experience, we may welcome someone to work in Madison, NJ. Madison, New Jersey (Gastroenterology) Irvine, California (Neurology, Eye care, or Facial Aesthetics) Senior Medical Writer Scientific - Publications and Planning Responsible for assisting authors in the writing of scientific publications and effective implementation of the publications writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with multiple functional groups (eg, PK, Statistics, Health Outcomes) to ensure accurate and timely completion/delivery of publications. A Senior Medical Writer would be expected to work on publications that require in-depth product and scientific knowledge. Senior Medical writers should have a good working knowledge of biostatistics. Other activities, special projects, and assignments may be given. As a result, the percentage of time spent across roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects, and the requirements within the organization as a whole. The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Company policies, and procedures. Company policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives. Main Areas of Responsibilities: Medical Writing Writes and edits the content of scientific abstracts, posters, and manuscripts supportive of business and scientific objectives, with direction and/or guidance on medical data interpretation, publication strategy, and statistical data analysis from the PPT and external authors, as appropriate. Adhere to standardized publication processes and SOP requirements for all publishing projects. Coordinate the review, approval, submission, and production of publishing projects. General Compliance Act as subject matter expert regarding computer-based technologies utilized by the department. As assigned, maintain publication-tracking of documents, ensuring accurate, appropriate, and timely data entry. Therapeutic Area and Publishing Knowledge Learn and continually maintain therapeutic area and product knowledge and apply to publishing projects. Maintain current awareness of good publication practices and editorial policies and apply to publishing projects. Communications Communicate effectively across functional areas and within the Publishing Group to accomplish project objectives. Present information to appropriate individuals in a concise, clear, and objective manner. Requirements: - 3 years of relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D. - Ability to assimilate and interpret scientific content and translate information for appropriate audience. - Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy. - Experience in working with collaborative, cross-functional teams, including project management experience. - Knowledgeable of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. - Working knowledge of current electronic document management systems and information technology. - Excellent written and oral communication skills. - Proven ability to work independently and effectively in teams. - Organizes/reorganizes workload in accordance with project priorities and timelines with focus on execution. - Effectively demonstrate leadership and motivational skills. - Excellent planning, organization, and communication skills (written and oral). - Able to write clearly and accurately, have good analytical skills, and detail orientated. - Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment. Preferred Skills/Qualification - 3 years of experience in experimental design and clinical/preclinical data interpretation preferred. - Knowledge of biostatistics preferred. - American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical. Education - Bachelor of Science with 6-10 years' industry medical writing experience; or Bachelor's degree in English or communications with relevant science experience with 6-10 years' industry medical writing experience; or Masters of Science with 3-6 years of industry medical writing experience; or Doctoral degree with 2-4 years of industry medical writing experience.
Apertus Partners
Madison, New Jersey, United States
Apertus Partners is seeking a Site Start-Up Specialist in Madison, NJ. Description: I. POSITION SUMMARY: The Site Start-Up Specialist is responsible for executing study start-up for assigned protocols with the goal of meeting study start-up timelines. Monitor project plans to meet Site Initiation Readiness at the Investigator Meeting. Ensure the accuracy and quality of deliverables from clinical team and vendors. Maintain project metrics and provide status updates to senior management. II. PRIMARY JOB RESPONSIBILITIES: Capable of performing all of the activities and responsibilities with direction of the Site Start-Up Unit Manager, Global Monitoring Operations: Director, Associate Director, or designee as follows: 1. Delivers Business Results - Execute study start-up for assigned protocols within Forest Research Institute timelines by identifying clinical team needs, contracting and managing vendor supported tasks and tracking critical timelines. - Oversee Site Start-Up project budgets averaging $300,000 by actively working on budget development, providing oversight on spending to ensure maintenance of project budget, developing contingency plans and presentations for senior management if additional funding is required to meet project goals. - Monitor project plans and communicates and troubleshoots the leading and lagging indicators to meet Site Initiation Readiness at the Investigator Meeting. - Ensure the accuracy and quality of site start-up deliverables by reviewing deliverables in reference to Forest standards. - Review and report on deliverables of vendors. - Maintain the tracking of project metrics in Site Start-Up tracker and provide status updates. - Work with internal groups to meet deliverables (i.e. Patient Recruitment, Clinical Development, and Clinical Planning). 2. Enhances Organizational Performance - Manage information sharing (i.e. Site Start-Up tracker, Site Identification Tracking Tools). - Develop Standard Operating Procedures and Working Documents to document and communicate unit's processes and procedures. - Actively share new ideas for efficient and seamless processes during study team meetings. - Aggressively seek input from other departments on process improvement and implements process improvement for Site Start-Up initiatives. - Provide agendas, meeting minutes and manages follow up items for all Site Start-Up meetings that are assigned. - Follow standard processes for the collection and processing of study site start-up documents and site start-up information. - Proactively inform manager of down-turns in leading site start-up indicators - Maintain all aspects of Site Start-Up portal documentation by updating trackers and providing frequent study updates. 3. Demonstrates Personal Leadership - Provide oversight and direction to vendors related to site start up tasks by overseeing timely delivery of regulatory documents, reviewing documents for quality, providing feedback on quality of vendor deliverables and providing direction to vendor on task requirements and prioritization. - Attend clinical team and operational team meetings and provides updates on the timely execution of inter and intra-departmental milestones. - Schedule and lead site start-up meetings with clinical team and vendors to review any issues, items for escalation, regulatory document issues, and IRB status. - May mentor junior staff members to improve quality of outcomes and to maintain team morale. 4. Develops Human Capital - Train study team members on current process and study execution modalities - May deliver training to junior staff on site start-up execution and Forest policy and procedures. - Maintain professional relationships with team members, Forest staff and study site staff. - Set and meet personal and professional goals and objectives. III. ADDITIONAL JOB RESPONSIBILITIES: Estimated travel may be 10%. IV. POSITION QUALIFICATIONS: Education: Qualified candidates will have a bachelor's in life sciences or related field Experience: At least 2 years experience in clinical research Prefer candidate with prior experience as Study Start-Up Specialist but not mandatory Licensure/Credentials: None Knowledge, Skills, and Abilities Knowledge of FDA regulations required. Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook Experience with Adobe Acrobat Professional and Microsoft Access a plus Must possess excellent skill/ability in the following: Written and Oral Communication Presentation Delivery Planning and Organizing Decision Making, Judgment, and Problem Solving People Relationships, Influencing Others, Motivating Employees, Team Building Initiative and Accountability Proven ability to interact with different functional groups Ability to easily adapt to a changing environment
Feb 26, 2019
Contractor
Apertus Partners is seeking a Site Start-Up Specialist in Madison, NJ. Description: I. POSITION SUMMARY: The Site Start-Up Specialist is responsible for executing study start-up for assigned protocols with the goal of meeting study start-up timelines. Monitor project plans to meet Site Initiation Readiness at the Investigator Meeting. Ensure the accuracy and quality of deliverables from clinical team and vendors. Maintain project metrics and provide status updates to senior management. II. PRIMARY JOB RESPONSIBILITIES: Capable of performing all of the activities and responsibilities with direction of the Site Start-Up Unit Manager, Global Monitoring Operations: Director, Associate Director, or designee as follows: 1. Delivers Business Results - Execute study start-up for assigned protocols within Forest Research Institute timelines by identifying clinical team needs, contracting and managing vendor supported tasks and tracking critical timelines. - Oversee Site Start-Up project budgets averaging $300,000 by actively working on budget development, providing oversight on spending to ensure maintenance of project budget, developing contingency plans and presentations for senior management if additional funding is required to meet project goals. - Monitor project plans and communicates and troubleshoots the leading and lagging indicators to meet Site Initiation Readiness at the Investigator Meeting. - Ensure the accuracy and quality of site start-up deliverables by reviewing deliverables in reference to Forest standards. - Review and report on deliverables of vendors. - Maintain the tracking of project metrics in Site Start-Up tracker and provide status updates. - Work with internal groups to meet deliverables (i.e. Patient Recruitment, Clinical Development, and Clinical Planning). 2. Enhances Organizational Performance - Manage information sharing (i.e. Site Start-Up tracker, Site Identification Tracking Tools). - Develop Standard Operating Procedures and Working Documents to document and communicate unit's processes and procedures. - Actively share new ideas for efficient and seamless processes during study team meetings. - Aggressively seek input from other departments on process improvement and implements process improvement for Site Start-Up initiatives. - Provide agendas, meeting minutes and manages follow up items for all Site Start-Up meetings that are assigned. - Follow standard processes for the collection and processing of study site start-up documents and site start-up information. - Proactively inform manager of down-turns in leading site start-up indicators - Maintain all aspects of Site Start-Up portal documentation by updating trackers and providing frequent study updates. 3. Demonstrates Personal Leadership - Provide oversight and direction to vendors related to site start up tasks by overseeing timely delivery of regulatory documents, reviewing documents for quality, providing feedback on quality of vendor deliverables and providing direction to vendor on task requirements and prioritization. - Attend clinical team and operational team meetings and provides updates on the timely execution of inter and intra-departmental milestones. - Schedule and lead site start-up meetings with clinical team and vendors to review any issues, items for escalation, regulatory document issues, and IRB status. - May mentor junior staff members to improve quality of outcomes and to maintain team morale. 4. Develops Human Capital - Train study team members on current process and study execution modalities - May deliver training to junior staff on site start-up execution and Forest policy and procedures. - Maintain professional relationships with team members, Forest staff and study site staff. - Set and meet personal and professional goals and objectives. III. ADDITIONAL JOB RESPONSIBILITIES: Estimated travel may be 10%. IV. POSITION QUALIFICATIONS: Education: Qualified candidates will have a bachelor's in life sciences or related field Experience: At least 2 years experience in clinical research Prefer candidate with prior experience as Study Start-Up Specialist but not mandatory Licensure/Credentials: None Knowledge, Skills, and Abilities Knowledge of FDA regulations required. Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook Experience with Adobe Acrobat Professional and Microsoft Access a plus Must possess excellent skill/ability in the following: Written and Oral Communication Presentation Delivery Planning and Organizing Decision Making, Judgment, and Problem Solving People Relationships, Influencing Others, Motivating Employees, Team Building Initiative and Accountability Proven ability to interact with different functional groups Ability to easily adapt to a changing environment
Apertus Partners
Madison, New Jersey, United States
Apertus Partners is seeking a Feasibility Analytics Specialist in Madison, NJ. Description: The Feasibility Analytics Specialist collaborates with FACT Managers/Directors to develop recruitment strategies and implement site start-up activities including site identification and vendor management for CDA and Site Feasibility Questionnaire (SFQ) collection. They will support patient recruitment vendor selection and maintain patient recruitment vendor information and metrics data. The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all company policies and procedures. Collaborates with FACT Managers/Directors to develop recruitment strategies and implement site start-up activities including site identification proposals and vendor management, CDA and Site Feasibility Questionnaire (SFQ) collection, Master Site List compilation and de-duplication, recruitment and retention proposals and vendor selection recruitment study metrics Facilitates cross-functional team discussions around these activities and collaborates with FACT Managers/Directors, Clinical Trial Team (CTT) and external vendors. - Manages site identification process implementation, quality control, status and improvements, and maintains and tracks vendor contract status and spend - Maintains site identification related data via FACT Portal: Master Site List and Site Disposition Reports, proposals and metrics - Identifies, engages and works with recruitment and site optimization vendors - Analyzes recruitment vendor proposals and prepares comparison materials, leads vendor assessment and selection meetings and collects Scorecard results. Meets with CTT, Procurement, FACT and other functional groups if required to discuss and finalize vendor selection. - Schedules and leads recruitment vendor Kick-Off Meeting and final vendor assessment metrics meetings - Gathers recruitment metrics data, tracks and reports data of recruitment strategies/vendors and manages the inventory of recruitment tools and recruitment vendors - Schedules TCs for new vendor capability presentations with FACT team - Assists in preparing Recruitment surveys - Interacts with investigator networks and patient advocacy groups to improve therapeutic area knowledge, and to collaborate on patient awareness - Remains current with industry innovations and advances, especially pertaining to investigator/site matters to ensure awareness of relevant advances and technology in the areas of patient recruitment and retention. Minimum Requirements Education: - BS or BA degree in a quantitative field or equivalent work experience.Experience: - Minimum 3 years related work experience in a pharmaceutical, device company, or an advertising agency - Experience working with TV, radio, newspaper, direct mail, e-mail, social media, public relations agencies, and third party service providers (i.e., recruitment agencies, Call Centers), investigative sites Clinical research experience in a pharmaceutical company/CRO is a plus.Knowledge, Skills, and Abilities - Extremely detail-oriented and must be able to work independently and as part of a team. - Understands the clinical trial management process. - Excellent customer service, communication, planning & organizational skills - Strong computer skills (MS Word, Excel, PowerPoint) with an ability to understand and access and leverage technology alternatives - Demonstrated ability to handle multiple competing priorities effectively ability to work in a fast paced and team-oriented environment - Can effectively communicate with external parties.
Feb 25, 2019
Contractor
Apertus Partners is seeking a Feasibility Analytics Specialist in Madison, NJ. Description: The Feasibility Analytics Specialist collaborates with FACT Managers/Directors to develop recruitment strategies and implement site start-up activities including site identification and vendor management for CDA and Site Feasibility Questionnaire (SFQ) collection. They will support patient recruitment vendor selection and maintain patient recruitment vendor information and metrics data. The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all company policies and procedures. Collaborates with FACT Managers/Directors to develop recruitment strategies and implement site start-up activities including site identification proposals and vendor management, CDA and Site Feasibility Questionnaire (SFQ) collection, Master Site List compilation and de-duplication, recruitment and retention proposals and vendor selection recruitment study metrics Facilitates cross-functional team discussions around these activities and collaborates with FACT Managers/Directors, Clinical Trial Team (CTT) and external vendors. - Manages site identification process implementation, quality control, status and improvements, and maintains and tracks vendor contract status and spend - Maintains site identification related data via FACT Portal: Master Site List and Site Disposition Reports, proposals and metrics - Identifies, engages and works with recruitment and site optimization vendors - Analyzes recruitment vendor proposals and prepares comparison materials, leads vendor assessment and selection meetings and collects Scorecard results. Meets with CTT, Procurement, FACT and other functional groups if required to discuss and finalize vendor selection. - Schedules and leads recruitment vendor Kick-Off Meeting and final vendor assessment metrics meetings - Gathers recruitment metrics data, tracks and reports data of recruitment strategies/vendors and manages the inventory of recruitment tools and recruitment vendors - Schedules TCs for new vendor capability presentations with FACT team - Assists in preparing Recruitment surveys - Interacts with investigator networks and patient advocacy groups to improve therapeutic area knowledge, and to collaborate on patient awareness - Remains current with industry innovations and advances, especially pertaining to investigator/site matters to ensure awareness of relevant advances and technology in the areas of patient recruitment and retention. Minimum Requirements Education: - BS or BA degree in a quantitative field or equivalent work experience.Experience: - Minimum 3 years related work experience in a pharmaceutical, device company, or an advertising agency - Experience working with TV, radio, newspaper, direct mail, e-mail, social media, public relations agencies, and third party service providers (i.e., recruitment agencies, Call Centers), investigative sites Clinical research experience in a pharmaceutical company/CRO is a plus.Knowledge, Skills, and Abilities - Extremely detail-oriented and must be able to work independently and as part of a team. - Understands the clinical trial management process. - Excellent customer service, communication, planning & organizational skills - Strong computer skills (MS Word, Excel, PowerPoint) with an ability to understand and access and leverage technology alternatives - Demonstrated ability to handle multiple competing priorities effectively ability to work in a fast paced and team-oriented environment - Can effectively communicate with external parties.
Apertus Partners
Madison, New Jersey, United States
Apertus Partners is seeking a Senior Manager of R&D Procurement in Madison, NJ. Description: POSITION SUMMARY: The Senior Manager/Procurement Lead, R&D Procurement - HCP & KOL Services will manage the negotiation and contracting of services with Healthcare Professionals and Key Opinion Leaders providing short-term, off-site services to Company R&D organizations. The incumbent works closely with leaders across the Company Legal, Global R&D (including Clinical Development, Clinical Operations, Regulatory, Medical Affairs, Safety, and Health Economics Outcomes Research), Finance, and Global Procurement teams to ensure KOL and HCP agreements are managed proactively and within Company regulatory, compliance, and financial obligations. In collaboration with these teams this role is responsible for: - Requirement Definition: Prior to engaging HCPs and KOLs, work in close collaboration with Company business partners, identify and clearly document scope of intended services to ensure alignment across the Company team, clarity to HCPs and KOLs, and compliance to all Company regulatory and financial obligations; determine budget and fair market value ranges. - Request Proposals: Follow a high-quality, consistent, expeditious, and effective process to ensure that HCPs and KOLs are properly vetted and selected to support anticipated scope of the agreement. Prepare, finalize, and distribute requests to HCPs and KOLs, share HCP and KOL responses with internal stakeholders, compile and retain all necessary documentation, and ensure an objective and ethical selection decision. - Negotiate Agreements: Negotiate agreements with HCPs and KOLs using Company templates and with the support of Company functional and legal teams to ensure compliance to regulatory and financial obligations. Interact with the Regulatory, Compliance, Legal, Finance, and other departments, as needed, to achieve cross departmental alignment with respect to contract development, approval, execution, and management. Act as the central point of contact through execution of agreements. - Contract Management: Proactively support supplier management activities such as issue resolution and contract amendments, as necessary, as well as the retention of all contract approvals, contract documents, and all other relevant documents in an Company Contract Management System. - Cost Management: Proactively work with internal stakeholders to ensure that all potential opportunities for operational, quality, compliance, and financial efficiencies are identified, tracked, and implemented. Work within the range of Fair Market Value (FMV) for all agreements, with the objective of achieving the best possible value for Company within the FMV range. - Category Profile: Document and maintain a comprehensive profile for the R&D Procurement - HCP & KOL category. CATEGORY SCOPE: For the purpose of clarity and compliance to regulatory obligations and Company policy/process, Key Opinion Leaders (KOLs) and Healthcare Professionals (HCPs) are individuals with a degree in medicine, veterinary medicine, dentistry, nursing, one of the allied health professions, or a doctorate degree who is recognized among his/her peers for his/her expertise in a specific field of knowledge and who provides advisory services to Company expressly related to his or her area of expertise. The KOLs and HCPs contracted within R&D Procurement provide advisory services to Company. Individuals who do not hold one of the aforementioned degrees or any individual, including a KOL or HCP, who provides services and/or deliverables other than advisory services will not be managed by R&D Procurement and will be sourced or contracted through the appropriate Company Human Resources or Indirect Procurement teams (exclusions clearly outlined herein). Services excluded from the R&D Procurement - HCP and KOL category include those... (1) performed by an investigator (principal or sub) on a study sponsored or supported by Company, (2) individuals performing at least 160 hours of service for Company in one year (thereby requiring CIA training), (3) individuals regularly working within an Company site, (4) individuals requiring access to Company proprietary systems, issued a computer, and/or given access badges to Company facilities, (5) individuals listed in the Company Employee directory and/or having an Company systems/SAP profile, (6) individuals acting in a capacity normally associated with an employee (e.g. Project manager, Study Physician, etc.), (7) individuals acting in a capacity to represent Company externally, (8) individuals providing managerial, prioritization, or performance-related direction/oversight to Company employees or other Company consultants, and/or (9) any individual performing consulting, contingent labor, or other workforce modification activities on behalf of Company. II. PRIMARY JOB RESPONSIBILITIES: In alignment with Company core competencies, the incumbent must demonstrate the following behaviors and abilities: - Deliver Business Results: (1) understand Company business requirements, and clearly include these within HCP and KOL contracts, (2) demonstrate and apply functional knowledge, experiences, and management skills to promote team performance and continual improvement across the organization's work with R&D Procurement HCPs and KOLs, and (3) handle issue resolution for relevant agreements. - Enhance Organizational Performance: (1) foster clear, consistent, and open collaboration across the extended Company teams and HCPs/KOLs, (2) identify and pursue new ideas and constructive change to support improved execution from both Company and HCPs/KOLs, and (3) support the issue escalation process at the operational level and ensure timely escalation to senior leadership, as required. - Demonstrate Personal Leadership: (1) act with integrity, initiative, and sound judgment to reinforce trust, professionalism, and commitments, (2) communicate regularly, openly, and effectively within Company and to HCPs and KOLs, as appropriate, and (3) inspire and empower peers, Company team to achieve and exceed objectives. - Develop Human Capital: (1) attract, assemble, and retain a high-caliber, multidisciplinary team to support contracting activities, performance, relationships, and assessments, and (2) continuously develop self and others through both formal and informal training, skill development, communication, performance management and growth opportunities. III. ADDITIONAL JOB RESPONSIBILITIES: - Support multiple R&D Procurement categories and projects, as assigned. - Effectively project manages all initiatives. IV. POSITION QUALIFICATIONS: Education: - Required: Bachelor's degree in business or relevant technical discipline. A Plus: Advanced Degree/Certificate in relevant field Experience: - This is a first-level manager position; 5 years in biotechnology/ pharmaceutical industry, experience in a clinical outsourcing/contracts function. Ideally, with direct HCP and KOL engagement. Licensure/Credentials: - None required, however a C.P.M., C.P.I.M., Project Management, Lean, Six Sigma, or other relevant certifications a plus. Knowledge, Skills, and Abilities - Demonstrated ability to facilitate the contract management processes. - Excellent ability to communicate effectively with senior leaders and managers, both internally and externally. - Excellent business/financial acumen, proficient in leading and managing cross-functional teams. - Ability to lead, motivate, influence and drive change at all levels of the organization. - Ability to understand the factors affecting the finances and/or operations of suppliers. - Excellent global supplier management skills with ability foster and leverage professional relationships. - Ability to identify and solve complex contractual, process, operational business challenges, and know when to seek assistance. - Clear understanding of HCP and KOL obligations, fair market values, and relevant topics. - Willing to travel domestically and internationally 10-20% of the time.
Feb 22, 2019
Contractor
Apertus Partners is seeking a Senior Manager of R&D Procurement in Madison, NJ. Description: POSITION SUMMARY: The Senior Manager/Procurement Lead, R&D Procurement - HCP & KOL Services will manage the negotiation and contracting of services with Healthcare Professionals and Key Opinion Leaders providing short-term, off-site services to Company R&D organizations. The incumbent works closely with leaders across the Company Legal, Global R&D (including Clinical Development, Clinical Operations, Regulatory, Medical Affairs, Safety, and Health Economics Outcomes Research), Finance, and Global Procurement teams to ensure KOL and HCP agreements are managed proactively and within Company regulatory, compliance, and financial obligations. In collaboration with these teams this role is responsible for: - Requirement Definition: Prior to engaging HCPs and KOLs, work in close collaboration with Company business partners, identify and clearly document scope of intended services to ensure alignment across the Company team, clarity to HCPs and KOLs, and compliance to all Company regulatory and financial obligations; determine budget and fair market value ranges. - Request Proposals: Follow a high-quality, consistent, expeditious, and effective process to ensure that HCPs and KOLs are properly vetted and selected to support anticipated scope of the agreement. Prepare, finalize, and distribute requests to HCPs and KOLs, share HCP and KOL responses with internal stakeholders, compile and retain all necessary documentation, and ensure an objective and ethical selection decision. - Negotiate Agreements: Negotiate agreements with HCPs and KOLs using Company templates and with the support of Company functional and legal teams to ensure compliance to regulatory and financial obligations. Interact with the Regulatory, Compliance, Legal, Finance, and other departments, as needed, to achieve cross departmental alignment with respect to contract development, approval, execution, and management. Act as the central point of contact through execution of agreements. - Contract Management: Proactively support supplier management activities such as issue resolution and contract amendments, as necessary, as well as the retention of all contract approvals, contract documents, and all other relevant documents in an Company Contract Management System. - Cost Management: Proactively work with internal stakeholders to ensure that all potential opportunities for operational, quality, compliance, and financial efficiencies are identified, tracked, and implemented. Work within the range of Fair Market Value (FMV) for all agreements, with the objective of achieving the best possible value for Company within the FMV range. - Category Profile: Document and maintain a comprehensive profile for the R&D Procurement - HCP & KOL category. CATEGORY SCOPE: For the purpose of clarity and compliance to regulatory obligations and Company policy/process, Key Opinion Leaders (KOLs) and Healthcare Professionals (HCPs) are individuals with a degree in medicine, veterinary medicine, dentistry, nursing, one of the allied health professions, or a doctorate degree who is recognized among his/her peers for his/her expertise in a specific field of knowledge and who provides advisory services to Company expressly related to his or her area of expertise. The KOLs and HCPs contracted within R&D Procurement provide advisory services to Company. Individuals who do not hold one of the aforementioned degrees or any individual, including a KOL or HCP, who provides services and/or deliverables other than advisory services will not be managed by R&D Procurement and will be sourced or contracted through the appropriate Company Human Resources or Indirect Procurement teams (exclusions clearly outlined herein). Services excluded from the R&D Procurement - HCP and KOL category include those... (1) performed by an investigator (principal or sub) on a study sponsored or supported by Company, (2) individuals performing at least 160 hours of service for Company in one year (thereby requiring CIA training), (3) individuals regularly working within an Company site, (4) individuals requiring access to Company proprietary systems, issued a computer, and/or given access badges to Company facilities, (5) individuals listed in the Company Employee directory and/or having an Company systems/SAP profile, (6) individuals acting in a capacity normally associated with an employee (e.g. Project manager, Study Physician, etc.), (7) individuals acting in a capacity to represent Company externally, (8) individuals providing managerial, prioritization, or performance-related direction/oversight to Company employees or other Company consultants, and/or (9) any individual performing consulting, contingent labor, or other workforce modification activities on behalf of Company. II. PRIMARY JOB RESPONSIBILITIES: In alignment with Company core competencies, the incumbent must demonstrate the following behaviors and abilities: - Deliver Business Results: (1) understand Company business requirements, and clearly include these within HCP and KOL contracts, (2) demonstrate and apply functional knowledge, experiences, and management skills to promote team performance and continual improvement across the organization's work with R&D Procurement HCPs and KOLs, and (3) handle issue resolution for relevant agreements. - Enhance Organizational Performance: (1) foster clear, consistent, and open collaboration across the extended Company teams and HCPs/KOLs, (2) identify and pursue new ideas and constructive change to support improved execution from both Company and HCPs/KOLs, and (3) support the issue escalation process at the operational level and ensure timely escalation to senior leadership, as required. - Demonstrate Personal Leadership: (1) act with integrity, initiative, and sound judgment to reinforce trust, professionalism, and commitments, (2) communicate regularly, openly, and effectively within Company and to HCPs and KOLs, as appropriate, and (3) inspire and empower peers, Company team to achieve and exceed objectives. - Develop Human Capital: (1) attract, assemble, and retain a high-caliber, multidisciplinary team to support contracting activities, performance, relationships, and assessments, and (2) continuously develop self and others through both formal and informal training, skill development, communication, performance management and growth opportunities. III. ADDITIONAL JOB RESPONSIBILITIES: - Support multiple R&D Procurement categories and projects, as assigned. - Effectively project manages all initiatives. IV. POSITION QUALIFICATIONS: Education: - Required: Bachelor's degree in business or relevant technical discipline. A Plus: Advanced Degree/Certificate in relevant field Experience: - This is a first-level manager position; 5 years in biotechnology/ pharmaceutical industry, experience in a clinical outsourcing/contracts function. Ideally, with direct HCP and KOL engagement. Licensure/Credentials: - None required, however a C.P.M., C.P.I.M., Project Management, Lean, Six Sigma, or other relevant certifications a plus. Knowledge, Skills, and Abilities - Demonstrated ability to facilitate the contract management processes. - Excellent ability to communicate effectively with senior leaders and managers, both internally and externally. - Excellent business/financial acumen, proficient in leading and managing cross-functional teams. - Ability to lead, motivate, influence and drive change at all levels of the organization. - Ability to understand the factors affecting the finances and/or operations of suppliers. - Excellent global supplier management skills with ability foster and leverage professional relationships. - Ability to identify and solve complex contractual, process, operational business challenges, and know when to seek assistance. - Clear understanding of HCP and KOL obligations, fair market values, and relevant topics. - Willing to travel domestically and internationally 10-20% of the time.
