Senior Clinical Study Manager
Core
Lead planning, start-up, and execution of US and global first-in-human and pivotal pre-market clinical trials for medical devices to support regulatory approvals.
Role type
Senior Clinical Study Manager (IC)
Builds
Pre-market and post-market clinical studies for medical device regulatory submissions
Domain
Medical Devices / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device trial management, protocol and ICF development, regulatory submission writing, scientific literature appraisal, clinical monitoring oversight, CRO management, site selection and start-up, clinical study reporting, cross-functional team leadership, GCP/FDA regulation knowledge, contract negotiation
Preferred skills
Hospital environment experience, statistical knowledge, outcomes research expertise
Technologies
EDC systems, Electronic Data Capture
Responsibilities
Design and develop clinical protocols and study documents, lead site selection and initiation, oversee CRA/CTA monitoring activities, conduct source data verification, manage study budgets and vendor contracts, prepare manuscripts and regulatory submissions, mentor junior study managers
Seniority
Senior, hands-on IC with mentorship responsibilities
