Clinical Trial Manager, Class III Medical Devices
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Job Description
Clinical Trial Manager coordinating Class III implantable-device trials at Biogen, a biotechnology company. Managing sites, vendors, compliance, risks, and regulatory workflows.
Responsibilities:
- Manage day-to-day execution and coordination of clinical trials for Class III medical devices
- Track study activities, timelines, deliverables, and operational issues with cross-functional team members
- Coordinate with study sites, CROs, and external vendors to ensure protocol-required activities meet timelines and quality expectations
- Monitor study progress and operational metrics, identifying risks and issues affecting timelines and data quality
- Support vendor oversight and site management by reviewing performance and operational quality concerns
- Collaborate with Safety, Regulatory, Quality, and Data Management teams
- Assist with documentation, vendor oversight activities, 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 such as action item logs and issue trackers
Requirements:
- Bachelor’s degree; advanced degree preferred
- At least 5 years of experience in clinical research or clinical operations
- Experience supporting clinical trials for Class III implantable medical devices
- Strong organizational and communication skills
- Ability to track study progress and identify operational risks
- Knowledge of regulatory and quality standards in clinical trials
- Experience with vendor oversight and site management
- Familiarity with regulatory submissions and protocol amendments
- Expertise in safety reporting workflows and managing study changes
Benefits:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
- Short term and long-term incentives, including cash bonus and equity incentive opportunities
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