Clinical Trial Manager, Class III Medical Devices

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $117k - $156.8k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Biogen is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological diseases, including Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. With a strong emphasis on research and development, Biogen continues to advance the science of neurology through clinical trials and strategic partnerships, while also striving for access and health equity in healthcare.

📋 Description

• 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