Director, Clinical Data Management Job at The Lotus Group LLC, San Mateo, CA

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  • The Lotus Group LLC
  • San Mateo, CA

Job 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.

Job Tags

Remote work, Relocation

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