Sr. Manager, Clinical Research and Post Market Clinical at Integra LifeSciences in Princeton, NJ
SUMMARY DESCRIPTION Reporting into the Senior Director, Clinical Operations, the Senior Manager, Clinical Research and PMCF Strategy will work proactively and collaboratively with cross-functional colleagues to support the planning, development, and scheduling of all aspects of Post-Market Clinical Follow-Up (PMCF) Plans to enable product development and commercialization. They will be a key intermediary between Clinical Operations, Regulatory Affairs, Medical Communication and Information, Medical Affairs, and Marketing to understand PMCF Plan needs, especially as related to regulatory and commercial requirements, to design executable PMCF Plans which support products' IFU. Further, this individual will liaise with and oversee work provided by external contract research organizations (CROs) who support planning and conduct of aspects of the PMCF Plans. By fulfilling these responsibilities, the individual will assure the effective design and conduct of PMCF Plans which support regulatory submissions and generation of clinical evidence for the company's products. Additionally, they will work proactively and collaboratively with other Clinical Operations colleagues to ensure the successful planning, resourcing, delivery, and communication of the entire portfolio of clinical studies. PMCF Plan Development and Execution:
Lead the gathering and evaluation of existing clinical evidence to form a foundation for decision making in PMCF Planning. Opinions should be formulated with internal (e.g. Medical Communication and Information, Regulatory Affairs) and external (e.g. contract research organizations (CROs)) subject matter experts (SMEs). Oversee the review and cataloguing of documents related to PMCF Plan design including study synopses, clinical evaluation reports, technical files, design dossiers, and internal and external literature to ensure robust planning. Synthesize available information and gaps in information about products to understand needs for PMCF Plan development and execution as it relates to scientific, regulatory, and commercial goals. Activities must be coordinated with internal stakeholders such as Regulatory Affairs, Medical Communication and Information, and Marketing. Lead development of PMCF study synopses (e.g. surveys, registries, single-arm studies, etc.) that will fulfil clinical evidence requirements leveraging internal and external SMEs, as applicable. Define scope (e.g. number of patients required), cost (including breakdown of cost over time), and timing for conduct of said clinical study to be incorporated into wider project portfolio and budget. Develop recommendations on feasibility of a PMCF project and Return On Investment (ROI) for communication to internal stakeholders involved in the decision-making process. Create alignment between key stakeholders such as Marketing (e.g. ROI), Clinical Operations (e.g. resource availability and planning), Medical Affairs (e.g. applicability of endpoints), and Regulatory (e.g. fulfilment of CE registration requirements) on proposed study synopsis so that additional PMCF Plan development can be initiated. Oversee development of full PMCF Plans according to all applicable GSOPs and current best practices for incorporation into the product's technical file. Incorporate study activities related to approved PMCF Plans into overall schedule of clinical research projects. Inform the decision on staffing of approved projects (e.g. insourcing versus outsourcing). Ensure availability and assignment of appropriate human resource support for clinical research projects, requesting additional resources as required. Ensure financial support for conduct of clinical research projects and incorporate into appropriate budgetary tools and financial systems, ensuring appropriate timing and phasing of required funds Oversee the successful execution of PMCF Plans and related clinical research projects as assigned in conjunction with CROs and/or the Clinical Operations department. Oversee development of annual and final PMCF study reports for submission to appropriate notified bodies. Ensure appropriate reporting of results in compliance with external requirements. Portfolio Management for Clinical Projects:
Ensure reported all clinical project plans are anchored on standard Key Performance Indicators (KPIs) and entered in appropriate business systems (e.g. GenSight). Generate resource models reflective of approved clinical project plans and validate those models with appropriate stakeholders (e.g. Clinical Operations Management, Clinical Research Managers). Ensure reported plans can be utilized for activities such as resource planning and gap analysis. Communicate portfolio, project, and resource status and requirements to stakeholders (e.g. CSO leadership, divisions, Executive Leadership Team). Coordinate within the Global Program Management (Office of the CSO) for the preparation and update of key project documents and systems (e.g. GenSight) to reflect Clinical Operations strategic and operational plans. Cross-Functional Team Support:
Prepare PMCF Planning documents supplied to regulatory bodies, both national and international, in support of product licensure and certifications. Liaise with the cross-functional team to ensure that product-specific information is considered and incorporated into PMCF Plan design. Provide routine updates to relevant and affected parties within the organization focusing on execution and budget management. Act as a subject matter expert for the clinical components of medical device regulations in the United States and internationally with a focus on FDA Code of Federal Regulations and EU Medical Device Regulations. Coordination, Communication, and Administration:
Lead or participate in quality and continuous improvement efforts to increase overall effectiveness of the Clinical Operations team. Interface with other departments (Quality, Legal, Regulatory, R&D) to represent the clinical department and ensure effective inter-department communication and collaboration. Represent the company at conferences, regulatory meetings, and relevant trade associations. Accurately complete administrative activities such as time reporting and expense reporting in a timely and accurate manner. Complete other assignments and responsibilities as required.
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Lead the gathering and evaluation of existing clinical evidence to form a foundation for decision making in PMCF Planning. Opinions should be formulated with internal (e.g. Medical Communication and Information, Regulatory Affairs) and external (e.g. contract research organizations (CROs)) subject matter experts (SMEs). Oversee the review and cataloguing of documents related to PMCF Plan design including study synopses, clinical evaluation reports, technical files, design dossiers, and internal and external literature to ensure robust planning. Synthesize available information and gaps in information about products to understand needs for PMCF Plan development and execution as it relates to scientific, regulatory, and commercial goals. Activities must be coordinated with internal stakeholders such as Regulatory Affairs, Medical Communication and Information, and Marketing. Lead development of PMCF study synopses (e.g. surveys, registries, single-arm studies, etc.) that will fulfil clinical evidence requirements leveraging internal and external SMEs, as applicable. Define scope (e.g. number of patients required), cost (including breakdown of cost over time), and timing for conduct of said clinical study to be incorporated into wider project portfolio and budget. Develop recommendations on feasibility of a PMCF project and Return On Investment (ROI) for communication to internal stakeholders involved in the decision-making process. Create alignment between key stakeholders such as Marketing (e.g. ROI), Clinical Operations (e.g. resource availability and planning), Medical Affairs (e.g. applicability of endpoints), and Regulatory (e.g. fulfilment of CE registration requirements) on proposed study synopsis so that additional PMCF Plan development can be initiated. Oversee development of full PMCF Plans according to all applicable GSOPs and current best practices for incorporation into the product's technical file. Incorporate study activities related to approved PMCF Plans into overall schedule of clinical research projects. Inform the decision on staffing of approved projects (e.g. insourcing versus outsourcing). Ensure availability and assignment of appropriate human resource support for clinical research projects, requesting additional resources as required. Ensure financial support for conduct of clinical research projects and incorporate into appropriate budgetary tools and financial systems, ensuring appropriate timing and phasing of required funds Oversee the successful execution of PMCF Plans and related clinical research projects as assigned in conjunction with CROs and/or the Clinical Operations department. Oversee development of annual and final PMCF study reports for submission to appropriate notified bodies. Ensure appropriate reporting of results in compliance with external requirements. Portfolio Management for Clinical Projects:
Ensure reported all clinical project plans are anchored on standard Key Performance Indicators (KPIs) and entered in appropriate business systems (e.g. GenSight). Generate resource models reflective of approved clinical project plans and validate those models with appropriate stakeholders (e.g. Clinical Operations Management, Clinical Research Managers). Ensure reported plans can be utilized for activities such as resource planning and gap analysis. Communicate portfolio, project, and resource status and requirements to stakeholders (e.g. CSO leadership, divisions, Executive Leadership Team). Coordinate within the Global Program Management (Office of the CSO) for the preparation and update of key project documents and systems (e.g. GenSight) to reflect Clinical Operations strategic and operational plans. Cross-Functional Team Support:
Prepare PMCF Planning documents supplied to regulatory bodies, both national and international, in support of product licensure and certifications. Liaise with the cross-functional team to ensure that product-specific information is considered and incorporated into PMCF Plan design. Provide routine updates to relevant and affected parties within the organization focusing on execution and budget management. Act as a subject matter expert for the clinical components of medical device regulations in the United States and internationally with a focus on FDA Code of Federal Regulations and EU Medical Device Regulations. Coordination, Communication, and Administration:
Lead or participate in quality and continuous improvement efforts to increase overall effectiveness of the Clinical Operations team. Interface with other departments (Quality, Legal, Regulatory, R&D) to represent the clinical department and ensure effective inter-department communication and collaboration. Represent the company at conferences, regulatory meetings, and relevant trade associations. Accurately complete administrative activities such as time reporting and expense reporting in a timely and accurate manner. Complete other assignments and responsibilities as required.
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
