Manager, Clinical Affairs

Job Description

The Manager, Clinical Affairs has management oversight for the execution of post-market studies, prospective and retrospective data collection, investigator- initiated studies, grants, and registries. This role is accountable for the successful completion of all project deliverables in accordance with company SOPs, GCP, and any applicable regulations.

The Manager, Clinical Affairs will drive the execution and implementation of systems, practices, and processes to ensure efficient and effective clinical operations including protocol development, trial management, data analysis, final study report and publication. This role directly manages internal clinical staff, Contract Research Organizations (CROs), and external consultants, with responsibility for resource allocation, budgeting, expense allocation, and project prioritization.

Essential Duties and Responsibilities:

• Manage a proficient clinical research operations team using internal and external resources (CROs, consultants, etc.).
• Oversee the operational aspects of clinical studies and data collection activities, ensuring timely execution of clinical activities including protocol development, trial timeline, budget, resources, sites and vendors (CROs, statistician, etc.), maintaining alignment with protocol requirements, internal procedures, applicable regulations, and good clinical practices.
• Responsible for overseeing post-market trial data analysis and reviewing and approving clinical study reports, ensuring data collection and reporting activities, compliant with all legal and regulatory requirements (HIPAA compliance, IRB approval, informed consent, etc.).
• Monitor and provide regular updates on study timelines, budgets, and risk mitigation activities.
• Analyze and report on trial performance to plan, ensuring swift issue resolution and development of corrective actions where necessary.
• Ensure proper supervision and training for all clinical study staff, CRO resources and field CRAs.
• Manage the Clinical Evaluation and Post Market Clinical Follow-up processes to ensure compliance with EU and UK regulations for CEPs, CERs, PMCF plans, and PMCF reports.
• Participate in cross-functional review of externally facing documents (e.g. clinical study reports, manuscripts, conference abstracts, marketing materials, regulatory submissions) to ensure accuracy and relevancy of presented data
• Remain current with relevant medical literature, clinical guidelines, societal and international committees, and industry trends.
• Collaborate cross-functionally with regulatory, legal, compliance and other departments as required.
• Attend and participate in regional, national, and international scientific and clinical meetings.
• Develop and foster relationships with key clinical customers (e.g., physicians, nurses, administrators, research staff).

Education and Experience:

• Bachelor’s degree in Life Sciences or related field. Advanced degree preferred
• Minimum of 5+ years of experience in clinical operations with at least 3 of those years in clinical study management; Medical Devices is preferred.
• Minimum of 2+ years of direct people management experience
• Demonstrated ability to provide coaching and feedback, including successful track record of hiring, professional staff development, and performance management
• Demonstrated ability to successfully design post-market clinical studies to support regulatory filings and sales/marketing data requirements; experience in medical devices preferred.
• Solid understanding of clinical regulations/guidelines and procedures (e.g., ICH/GCP, ISO 14155, CFR 820,
• EU MDD/MDR, UKCA); ability to work within the constraints of a regulated industry while achieving objectives
• Ability to travel up to 30%