Job Details

Director, Clinical Data Management

  2026-04-05     The Lotus Group LLC     Fremont,CA  
Description:

Global Pharmaceutical Company | Hybrid — Weekly On-Site Required

The Opportunity

A global pharmaceutical company is looking for a Director of Clinical Data Management to lead data operations across a growing clinical portfolio. This is a hands-on leadership role with a hybrid schedule that includes required weekly on-site presence. Candidates must be able to commute to site on a weekly basis — remote-only arrangements will not be considered.

What You'll Own

  • End-to-end CDM accountability across Phase I–III studies, from database design through database lock
  • Build, manage, and develop a high-performing CDM team
  • Drive CRF design, data validation specifications, edit check development, and data management planning
  • Oversee CRO and CDM vendor performance — scope, timelines, quality, and escalation
  • Lead CDISC/CDASH standards implementation and ensure consistency across the portfolio
  • Serve as the CDM functional lead on cross-functional study teams alongside Biostatistics, Clinical Operations, and Regulatory
  • Ensure inspection readiness across all active studies; represent CDM in regulatory audits as needed
  • Partner with IT and systems teams on EDC platform management and optimization

What We're Looking For

  • 10+ years of clinical data management experience in pharma, biotech, or CRO settings
  • 4+ years leading or managing CDM teams
  • Proven track record across multiple concurrent global trials, Phase I through III
  • Strong EDC platform experience (Medidata Rave or equivalent)
  • CDISC standards expertise — CDASH required, SDTM familiarity expected
  • Experience with multi-CRO oversight and risk-based monitoring models
  • Regulatory inspection experience (FDA, EMA, or equivalent) preferred
  • Direct communicator with the credibility to engage senior cross-functional stakeholders

Education

Bachelor's degree in a life sciences or related field required. Advanced degree a plus. CCDM certification viewed favorably.

Location & Schedule

Hybrid schedule with weekly on-site presence required. Candidates must reside within commuting distance or be open to relocation.


Apply for this Job

Please use the APPLY HERE link below to view additional details and application instructions.

Apply Here

Back to Search