Senior Clinical Study Manager
Core
Develop and execute strategies for clinical and outcomes research studies to support regulatory approvals and strategic evidence initiatives for medical devices.
Role type
Senior Clinical Study Manager (IC)
Builds
Clinical protocols, study reports, and regulatory submissions for pre-market and post-market studies
Domain
Medical Devices / Clinical Research
Required skills
Clinical study design, protocol development, regulatory compliance (GCP), site management, data verification, literature appraisal, contract negotiation, cross-functional leadership
Preferred skills
Hospital environment experience, statistical methods knowledge, surgical specialty familiarity
Technologies
EDC systems, IRB/EC submission platforms
Responsibilities
Lead assigned clinical research activities from site selection to close-out; conduct site qualification and monitoring visits; verify source data in EDC systems; liaise with investigators and vendors; mentor junior managers; prepare manuscripts and regulatory submissions; manage study budgets and timelines
Seniority
Senior, hands-on IC
