Remote Clinical Trial Manager, Class III Medical Devices

Biogen, Inc.; Northern (KY); Hybrid; USD 117,000 - 157,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Fitness reimbursement

Vacation time

Paid holidays

Sick time

Parental leave

401(k) matching

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen is seeking a Clinical Trial Manager for Class III medical devices to lead day-to-day trial operations in a remote, USA-based role. You will coordinate with sites, CROs, and vendors, ensuring timelines and quality standards are met while supporting regulatory submissions and safety workflows.

The role emphasizes risk tracking, data quality, and cross-functional collaboration with Safety, Regulatory, and Data Management teams to drive successful clinical trials under the Implantable Device

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.
• 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 with cross-functional teams.
• Coordinate with study sites, CROs, and external vendors to ensure protocol activities meet timelines and quality.
• Monitor study progress and identify risks affecting timelines and data quality.
• 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 study continuity.
• Support regulatory submissions, protocol amendments, and safety reporting workflows.
• Organize follow-up activities like action item logs and issue trackers.

Job description

Biogen is seeking a Clinical Trial Manager for Class III medical devices to lead day-to-day trial operations in a remote, USA-based role. You will coordinate with sites, CROs, and vendors, ensuring timelines and quality standards are met while supporting regulatory submissions and safety workflows.

The role emphasizes risk tracking, data quality, and cross-functional collaboration with Safety, Regulatory, and Data Management teams to drive successful clinical trials under the Implantable Device