Clinical Trial Manager, Class III Medical Devices
Core
Planning, coordination, and execution of clinical trials for Class III implantable medical devices to ensure safety, efficacy, and regulatory compliance.
Role type
Management-level Clinical Trial Manager
Builds
Clinical trial operations for Class III implantable medical devices
Domain
Medical Devices / Clinical Research
Deliverable
client delivery
Required skills
Clinical trial management, Class III implantable device expertise, vendor oversight, site management, regulatory standards knowledge, safety reporting workflows, protocol amendment management, risk identification, stakeholder coordination
Preferred skills
Advanced degree, experience with regulatory submissions
Technologies
None stated
Responsibilities
Manage day-to-day execution and coordination of clinical trials; Track study activities, timelines, and operational issues; Coordinate with study sites, CROs, and external vendors; Monitor study progress and operational metrics; Support vendor oversight and site management; Collaborate with Safety, Regulatory, Quality, and Data Management teams; Assist with documentation and site management processes; Facilitate communication among internal team members, CROs, and sites; Support regulatory submissions, protocol amendments, and safety reporting workflows; Organize and track follow-up activities like action item logs and issue trackers
Seniority
Management level
