Remote Clinical Trial Manager, Class III Medical Devices

Remote Jobs; United States; Remote; USD 117,000 - 157,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Short- and Long-Term Disability

Paid vacation + year-end shutdown

Company 401(k) with match

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen seeks a Clinical Trial Manager to lead planning, coordination, and execution of Class III medical device trials from remote locations in the United States. You will work with cross-functional partners, study sites, and CROs to ensure protocol activities are performed on time and to the highest quality standards.

Responsibilities include tracking progress, managing risks, supporting submissions and safety workflows, and coordinating with Safety, Regulatory, Quality, and Data teams to drive

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• At least 5 years of experience in clinical research or operations.
• Experience with Class III implantable medical device trials.
• 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 study changes.

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 partners.
• Coordinate with study sites, CROs, and vendors to ensure protocol activities meet timelines and quality.
• Monitor study progress and metrics, identifying risks and data quality issues.
• Support vendor oversight and site management by reviewing performance and 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 teams, CROs, and sites to maintain continuity.
• Support regulatory submissions, protocol amendments, and safety reporting workflows.
• Organize follow-up activities like action logs and issue trackers.

Skills

Clinical trial management

Regulatory compliance

Vendor oversight

Cross-functional coordination

Data quality oversight

Communication skills

Education

Bachelor’s degree; advanced degree preferred

Job description

Biogen seeks a Clinical Trial Manager to lead planning, coordination, and execution of Class III medical device trials from remote locations in the United States. You will work with cross-functional partners, study sites, and CROs to ensure protocol activities are performed on time and to the highest quality standards.

Responsibilities include tracking progress, managing risks, supporting submissions and safety workflows, and coordinating with Safety, Regulatory, Quality, and Data teams to drive