R&D Manager, Clinical Research
Core
Manage clinical research function including internal product evaluations, clinical studies, and quality improvement projects to support medical device product development.
Role type
Manager, Clinical Research
Builds
Clinical evidence for Medline product development and post-market activities
Domain
Medical device / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical research management, project execution, regulatory compliance (GCP), team leadership, budget management, risk assessment, cross-functional collaboration
Preferred skills
Cross-functional team supervision, concurrent project coordination, knowledge of FDA clinical requirements (IDE, 21 CFR), ISO 14155 familiarity, post-market clinical evidence experience
Technologies
GCP, FDA regulations, ISO 14155
Responsibilities
Manage team executing clinical research activities, plan and allocate resources for clinical projects, collaborate on study strategies and execution plans, oversee design and execution of clinical studies, partner with customers for quality improvement, identify project risks and develop contingency plans, ensure regulatory compliance, monitor emerging clinical trends
Seniority
Manager, hands-on leadership