Senior CDM Lead: Cancer Trials & Cross-Functional Impact

Gilead Sciences Inc.

United States

Remote

USD 143,000 - 185,000

Full time

11 days ago

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Job summary

Kite Pharma seeks a Senior Manager, CDM to oversee data management for NIS studies and support Investigator Sponsored Research. You will lead cross-functional teams, ensure data integrity, and drive timelines across internal and vendor partners.

Ideal candidates bring 10+ years in clinical data management with CDISC standards, strong leadership, and experience with major EDC systems. This role emphasizes regulatory readiness and collaboration across Clinical Operations and Medical Affairs.

Qualifications

  • Lead in clinical data management deliverables for regulatory filings
  • Experience managing NIS studies in an oversight capacity
  • 10+ years of industry experience in clinical trials and leadership through influence
  • Experience with CDISC standards (CDASH/SDTM/ADaM)

Responsibilities

  • Drive and execute management of CDM deliverables within Kite sponsored NIS program.
  • Provide support on non-Kite sponsored collaborative and ISR studies.
  • Define Kite CDM strategy and processes for these studies.
  • Build relationships with Clinical Operations, Medical Affairs, Translational Medicine to understand study requirements.
  • Communicate DM timelines and oversee study status with CRO counterparts.
  • Lead CDM representatives during internal and Health Authority audits.
  • Develop and implement CDM processes, SOPs, and related documents.
  • Mentor and train CDM roles; participate in cross-functional initiatives.

Skills

CDM leadership
Cross-functional collaboration
Project management
Communication
Mentoring

Education

Bachelor's Degree (or higher) in a related field
Masters' Degree (optional)
PhD / PharmD (preferred)
High School diploma with extensive experience

Tools

Medidata Rave
Veeva EDC
Medrio EDC
Oracle
TrialGrid

Job description

Kite Pharma seeks a Senior Manager, CDM to oversee data management for NIS studies and support Investigator Sponsored Research. You will lead cross-functional teams, ensure data integrity, and drive timelines across internal and vendor partners.

Ideal candidates bring 10+ years in clinical data management with CDISC standards, strong leadership, and experience with major EDC systems. This role emphasizes regulatory readiness and collaboration across Clinical Operations and Medical Affairs.

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