Clinical Trial Manager
Core
Lead day-to-day execution of U.S. clinical activities for structural heart technologies, including site management, enrollment, and vendor oversight.
Role type
Senior IC clinical trial manager (medical devices)
Builds
U.S. IDE and post-market clinical studies for structural heart devices
Domain
Medical devices / Structural heart disease / Interventional cardiology
Required skills
site activation, patient enrollment, clinical monitoring, data quality management, CRO management, safety event reporting, protocol compliance, investigator relations
Preferred skills
U.S. IDE study experience, structural heart device experience, interventional cardiology experience
Technologies
GCP, ISO 14155, FDA regulations
Responsibilities
Lead execution of U.S. IDE and post-market clinical studies; Visit clinical sites and maintain relationships with investigators; Drive site activation, enrollment, and monitoring; Oversee CROs and clinical vendors; Support collection of clinical safety events and protocol deviations; Ensure compliance with study protocols and regulations.