Senior Manager Clinical Affairs
Core
Senior Manager leading clinical strategies and overseeing execution of first-human-use and pivotal clinical trials for emerging surgical technologies, supporting regulatory submissions and evidence dissemination.
Role type
Senior Manager, Clinical Affairs (Functional Manager)
Builds
Clinical study protocols, regulatory submissions, and clinical evidence packages for surgical technology products.
Domain
Medical Devices / Surgical Robotics / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial management, cross-functional leadership, budget and resource management, regulatory strategy, protocol development, stakeholder management (KOLs, sites, CROs), team development, compliance with GCP/FDA regulations.
Preferred skills
MD/PhD, experience in surgical technology, audit support, statistics understanding.
Technologies
GCP, 21 CFR part 812, ISO14155, CRF, SAP.
Responsibilities
Develop clinical study strategies to meet business goals; manage clinical protocols and documents for regulatory submission; lead a team of clinical study managers and research associates; manage study budgets and resources; collaborate with Regulatory Affairs and R&D; ensure compliance with regulatory guidelines; build relationships with investigational sites and investigators.
Seniority
Senior Manager, hands-on leadership with strategic oversight
