Senior Manager, Clinical Affairs
Core
Lead clinical strategies and oversee execution of first-human-use and pivotal clinical trials for emerging medical technologies, ensuring regulatory submission readiness and evidence dissemination.
Role type
Senior Manager, Clinical Operations & Strategy
Builds
Clinical study protocols, regulatory submissions, and clinical evidence packages for medical device technologies.
Domain
Medical Devices / Surgical Technology / Clinical Research
Required skills
Clinical trial management, regulatory strategy, cross-functional leadership, budget management, protocol development, KOL engagement, GCP compliance, statistical analysis oversight, team development.
Preferred skills
MD/PhD, surgical technology familiarity, audit experience, hospital environment experience.
Technologies
GCP, 21 CFR part 812, ISO14155, SAP, CRF.
Responsibilities
Develop clinical study strategies to meet business goals; manage resources and study budgets; collaborate with Regulatory Affairs on submissions; build relationships with investigational sites and investigators; guide data management and biostats teams; ensure compliance with corporate and regulatory requirements; lead and develop a team of clinical study managers and research associates.
Seniority
Senior Manager, hands-on leadership with strategic oversight.