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Associate Director/ Senior Manager, Value Evidence and Outcome - Japan

Insmed · Japan

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OtherFull-time$164k–$206kCompany career page

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What they're looking for

  • Bachelor's degree in science or healthcare-related field
  • Minimum 8 years progressive clinical data management experience in pharma, biotech, CRO, or regulatory agency
  • Second-line management and functional leadership experience
  • Vendor management experience with IWRS, imaging, PRO, and database technologies
  • Knowledge of ICH guidelines, CDASH, 21 CFR Part 11, and FDA requirements
  • Understanding of drug development and clinical trial data operations
  • Strong communication, decision-making, and negotiation skills

What you'll be doing

  • Provide leadership and oversight of clinical data management activities ensuring database accuracy and consistency
  • Develop and implement strategic vision for data management group and EDC system processes
  • Collaborate with CROs to prepare data management plans and manage projects end-to-end
  • Lead database cleaning, data reconciliation, and lock activities in EDC systems
  • Oversee adverse event and medical coding review with coordination of medical monitor approval

Privacy & handoff

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What RoleLantern checked

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