Senior Clinical Study Manager
Core
Lead pre-market and post-market clinical studies for medical devices to generate evidence for regulatory approvals and strategic initiatives.
Role type
Senior Clinical Study Manager
Builds
Clinical evidence, regulatory submissions, and scientific publications
Domain
Medical devices / Clinical research
Required skills
Clinical study design, protocol development, site management, regulatory compliance (ICH/GCP), data verification, literature appraisal, project management, contract negotiation, cross-functional leadership
Preferred skills
Hospital environment experience, statistics knowledge, surgical specialty familiarity (via careerplan.io/jobs/271a2fb9-5e3f-40da-aa4c-b5442b121456-senior-clinical-study-manager-at-jobgether)
Technologies
EDC systems, IRB/EC submission platforms
Responsibilities
Develop study concepts, designs, and protocols; execute site selection, recruitment, and monitoring; perform source data verification; manage study timelines and budgets; support regulatory submissions and audit readiness; mentor junior staff; collaborate on scientific publications and manuscripts.
Seniority
Senior, hands-on IC with mentorship responsibilities