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Director of Clinical Data Management

zentalis · Remote or San Diego

Remote
Remote Senior 🇬🇧 English
CDISC SDTM CFR-Part 11 GCP ICH

Job description

About the role

Zentalis, a clinical oncology innovator, is seeking a Director of Clinical Data Management to lead all data management activities from study start‑up through close‑out. The role will shape data standards, oversee vendor relationships, and ensure high‑quality data delivery for our oncology programs.

Key responsibilities

  • Lead and supervise the Clinical Data Management function, including staffing and resource planning.
  • Develop and enforce corporate data standards, CDISC/SDTM implementation, and CFR‑Part 11 compliance.
  • Manage vendor/CRO contracts, budgets, and timelines to meet project goals.
  • Collaborate cross‑functionally to resolve data issues throughout the drug development lifecycle.
  • Provide oversight for regulatory audits and ensure data quality and cost efficiency.

Required profile

  • BS/MS in life sciences or a related field.
  • 8‑10+ years of direct clinical data management experience in pharma or CRO environments.
  • Proven supervisory and mentoring abilities with a hands‑on management style.
  • Strong project‑management expertise and experience working with CROs/vendors.

Required skills

  • CDISC standards
  • SDTM requirements
  • CFR‑Part 11 compliance
  • Good Clinical Practice (GCP)
  • International Council for Harmonisation (ICH) guidelines

Questions fréquentes

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Source : ats:bamboohr

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Published 2 weeks ago

Expires 1 month from now

18 views · 0 interested

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zentalis

Remote or San Diego