Clinical Trial Manager, Class III Medical Devices

Biogen

. Manage day-to-day execution and coordination of clinical trials for Class III medical devices .

Posted 9/23/2026full-timeRemote • United StatesMid-LevelSenior💰 $117,000 - $156,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical trials for Class III medical devices, with a strong focus on regulatory compliance, vendor oversight, and effective communication across cross-functional teams.

Highest-signal resume keywords

Clinical Research ExperienceClass III Medical Device TrialsRegulatory SubmissionsVendor OversightSafety Reporting Workflows

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementOperational Metrics TrackingRisk IdentificationProtocol AmendmentsDocumentation Support

Soft Skills

Strong Organizational SkillsEffective Communication Skills

Industry Keywords

Clinical OperationsRegulatory StandardsQuality StandardsSite ManagementCRO Coordination

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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