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Dexcom logo
Dexcom

Empowering people to take control of health

Manager, Clinical Quality and Compliance

ComplianceComplianceFull TimeRemoteSeniorTeam 10,001+Since 1999H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

58 days ago

Salary

$111.1K - $185.1K / year

Seniority

Senior

Bachelor Degree3 yrs expEnglish

Job Description

Manager, Clinical Quality and Compliance

Dexcom

• Promote a culture of quality. • Manage clinical safety oversight. • Implement measures to ensure product quality and patient safety. • Champion continuous improvement initiatives. • Review and approve clinical study protocols. • Lead the review and management of post-market clinical follow-up activities. • Develop and implement vendor qualification processes. • Lead or support internal and external audits as required. • Develop and maintain quality procedures and work instructions. • Lead the CAPA process, including investigation, root cause analysis, and implementation of corrective/preventive actions. • Review and approve validation protocols and reports. • Collaborate with cross-functional teams to address quality-related issues and drive improvements. • Oversee the management of the electronic trial master file system.

Job Requirements

  • Experience working in clinical research and knowledge of clinical trial design and analysis.
  • Minimum of 3 years in Clinical Quality role.
  • Experience in audit support.
  • Excellent communication and presentation skills, with the ability to communicate results and insights to non-technical stakeholders.
  • Ability to work independently and collaboratively in a team environment.
  • Familiarity with continuous glucose monitoring devices and diabetes management is a plus.

Benefits

  • A full and comprehensive benefits program.
  • Growth opportunities on a global scale.
  • Access to career development through in-house learning programs and/or qualified tuition reimbursement.
  • An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

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