Senior Clinical Study Manager
Core
Develop and execute strategies for clinical and outcomes research studies to support regulatory approvals and key strategic evidence initiatives for medical devices.
Role type
Senior Clinical Study Manager (Pre-market & Post-market)
Builds
Clinical study reports, regulatory submissions (510k/PMA), manuscripts, and scientific publications
Domain
Medical Devices / Clinical Research / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
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 leadership
Preferred skills
Hospital environment experience, statistical methods knowledge, KOL management, global study experience
Technologies
EDC systems, Clinical trial agreements, IRB/EC submission platforms
Responsibilities
Lead assigned clinical research activities including site initiation, monitoring, and close-out; Collaborate with investigators and KOLs to develop study design and protocols; Conduct source data verification and ensure regulatory compliance; Mentor junior study managers and guide CRAs/CTAs; Support regulatory submissions and address FDA questions; Prepare manuscripts and presentations for scientific meetings.
Seniority
Senior, hands-on IC with mentorship responsibilities
