Our client, a growing medical device organization, is looking to add a Manager of Clinical Affairs to their team!
The Manager, Clinical Affairs oversees the execution of post-market studies, data collection efforts, investigator-initiated studies, grants, and registries, ensuring all projects comply with company SOPs, GCP, and applicable regulations. Responsibilities include managing internal staff, CROs, and consultants, along with overseeing budgets, resources, and project priorities.
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, 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
- Develop and foster relationships with key clinical customers.
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
- Ability to travel up to 30%