Clinical Trial Manager, Class III Medical Devices

Job 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