Clinical Trial Manager, Class III Medical Devices

Clinical Trial Manager responsible for planning, coordinating, and executing clinical trials for Class III medical devices at Biogen. The role involves managing day-to-day trial operations, coordinating with sites and vendors, tracking progress and risks, and ensuring compliance with regulatory and quality standards.

Responsibilities

• Manage day-to-day execution and coordination of Class III medical device clinical trials
• Track study activities, timelines, deliverables, and identify operational risks affecting data quality
• Coordinate with study sites, CROs, and external vendors to ensure protocol-required activities meet timelines and quality expectations
• Collaborate with internal stakeholders including Safety, Regulatory, Quality, and Data Management teams
• Support regulatory submissions, protocol amendments, safety reporting, and maintain study documentation

Requirements

• Bachelor's degree; advanced degree preferred
• At least 5 years of clinical research or clinical operations experience
• Experience supporting Class III implantable medical device clinical trials
• Strong organizational and communication skills
• Knowledge of regulatory and quality standards in clinical trials
• Experience with vendor oversight and site management
• Familiarity with regulatory submissions, protocol amendments, and safety reporting

Compensation: $117,000-$156,750 base