Senior Manager, Clinical Science

ManagerManagerFull TimeRemoteTeam 501-1,000Since 2001H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

15 days ago

Salary

$145K - $180K / year

Bachelor Degree6 yrs expEnglish

Job Description

• Provide clinical and scientific leadership for medical device evidence generation across the product lifecycle • Ensure clinical evidence support for regulatory compliance, physician adoption, and patient outcomes • Lead development and execution of Clinical Evidence Plans (CEP) aligned with product lifecycle needs • Translate evidence strategy into clinical protocols and Clinical Evaluation Reports (CERs) • Provide scientific leadership for device clinical studies and Review and author: Clinical protocols and Informed Consent Forms (ICF) • Collaborate with Regulatory Affairs on submissions, responses, and inspections • Support Market Access and HEOR with clinical value narratives when applicable • Work with Clinical Operations on the authorship and execution of safety management plans for current and future studies

Job Requirements

  • Degree in life sciences required
  • Clinical background or applied clinical research experience strongly preferred
  • 6–10+ years of experience in clinical science, medical affairs, or clinical development within medical devices
  • Hands-on experience with device clinical studies and/or registries
  • Post-market clinical evidence generation
  • Regulatory documentation (CER, CEP, PMCF)
  • Experience supporting FDA, EU MDR, and/or global regulatory interactions preferred

Benefits

  • Health insurance
  • Dental insurance
  • Vision insurance
  • 401(k) plan plus employer contribution and match
  • Generous paid leaves such as vacation and sick leave
  • Paid volunteer time
  • Annual performance bonus incentive plan
  • Company-sponsored benefits
  • Wellbeing programs

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