Director, Clinical Data Management

Added
6 hours ago
Type
Full time
Salary
Salary not provided

Related skills

regulatory submissions ecoa ich-gcp cdisc sdtm medidata rave

📋 Description

  • Lead sponsor-side data management for Phase 2/3 trials, esp. rare disease/neonatology.
  • Develop and execute data management strategies aligned with goals and timelines.
  • Serve as primary data management contact for internal stakeholders and external partners.
  • Oversee CROs, EDC providers, central labs, imaging vendors, and other service providers.
  • Manage vendor performance across scope, budget, timelines, quality metrics.
  • Oversee database build, testing, deployment, maintenance, and lock.

🎯 Requirements

  • Bachelor’s degree in Life Sciences, Biostatistics, CS, Nursing, Public Health; advanced degree preferred.
  • 12–15+ years of clinical data management experience in biotech/pharma/CRO environments.
  • Strong preference for biotech experience and sponsor-side clinical data management leadership.
  • Experience leading global Phase 2/3 clinical trials.
  • Experience overseeing CROs and external vendors in outsourced model.
  • Strong knowledge of EDC platforms: Medidata Rave, Oracle InForm, Veeva Vault CDMS.

🎁 Benefits

  • Work on global clinical development programs with meaningful patient impact.
  • Exposure to innovative rare disease and specialty healthcare research.
  • Collaboration with international clinical, scientific, and operational teams.
  • Leadership role with significant ownership and strategic influence.
  • Opportunity to work with advanced clinical data platforms and regulatory processes.
  • Flexible remote work structure aligned with global collaboration.
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