Clinical Trial Manager, Class III Medical Devices

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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
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