Clinical Trial Manager — Class III Medical Devices

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

Benefits offered by this job

Medical/Dental/Vision/Life

Fitness reimbursement

Disability insurance

Vacation time

Paid holidays

Sick time

Parental leave

401(k) matching

Employee stock plan

Tuition reimbursement

ERGs

Job summary

Biogen is seeking a Clinical Trial Manager to oversee the planning, coordination, and execution of Class III medical device clinical trials. You will collaborate with cross-functional teams, sites, and CROs to ensure timelines, quality, and regulatory compliance.

You will monitor progress, manage risk, and support safety reporting workflows while coordinating vendor oversight and site management. Strong organizational and communication skills are essential for success in this role.

Qualifications

• 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.

Responsibilities

• Manage day-to-day execution and coordination of clinical trials for Class III medical devices.
• Track study activities, timelines, deliverables, and operational issues in partnership with cross-functional team members.
• Coordinate with study sites, CROs, and external vendors supporting class III medical device trials to ensure protocol-required activities are performed according to timelines and quality expectations.
• Monitor study progress and operational metrics for class III medical device trials, identifying risks and issues that may affect timelines and data quality.
• Support vendor oversight and site management for class III medical device clinical trials by reviewing performance and operational quality concerns.
• Collaborate with internal stakeholders such as 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 to maintain study continuity.
• Support regulatory submissions, protocol amendments, and safety reporting workflows.
• Organize and track class III medical device clinical trial follow-up activities like action item logs and issue trackers.

Skills

Organizational skills

Communication skills

Tracking study progress

Regulatory knowledge

Vendor oversight

Site management

Safety reporting

Protocol amendments

Education

Bachelor’s degree

Advanced degree

Job description

Biogen is seeking a Clinical Trial Manager to oversee the planning, coordination, and execution of Class III medical device clinical trials. You will collaborate with cross-functional teams, sites, and CROs to ensure timelines, quality, and regulatory compliance.

You will monitor progress, manage risk, and support safety reporting workflows while coordinating vendor oversight and site management. Strong organizational and communication skills are essential for success in this role.