Senior Clinical Study Manager
Core
Develop and execute strategies for clinical and outcomes research studies to support regulatory approvals and key strategic evidence initiatives.
Role type
Senior Clinical Study Manager (pre-market and post-market)
Builds
Clinical study reports, regulatory submissions (510k/PMA), scientific publications, and clinical strategies
Domain
Medical devices / Clinical research / Regulatory affairs
Required skills
Clinical study design, protocol development, site selection and management, regulatory compliance (GCP/ICH), literature review and appraisal, contract negotiation, data analysis interpretation, cross-functional team leadership
Preferred skills
Hospital environment experience, statistical methods knowledge, KOL management, global study experience
Technologies
EDC systems, Electronic Data Capture
Responsibilities
Lead assigned clinical research activities; plan and execute clinical studies including site initiation and close-out; conduct site monitoring and source data verification; collaborate with biostatisticians to develop clinical study reports; support regulatory submissions and address FDA questions; mentor junior staff; manage study budgets and vendor contracts
Seniority
Senior, hands-on IC with mentorship responsibilities
