Director, External Clinical Data Management Job at Meet Life Sciences, San Jose, CA

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  • Meet Life Sciences
  • San Jose, CA

Job Description

Job Title: Director, External Data Management

Location: SF Bay Area, CA and Philadelphia, PA | Onsite

We are seeking a Director, External Data Management to lead the management and integration of external data throughout the clinical trial lifecycle. The ideal candidate will bring expertise in handling diverse external data sources, including labs, biomarkers, and pharmacokinetics, with a focus on oncology. In this leadership role, you'll collaborate with internal teams, CROs, and service providers to ensure high-quality data transfer, integration, and analysis.

Key Responsibilities:

  • Lead external data management processes, including data transfer, reconciliation, and integration.
  • Develop Data Transfer Plans and collaborate with external partners to ensure protocol-compliant data.
  • Oversee edit check development, quality reviews, and query management.
  • Ensure timely, accurate data for regulatory submissions.
  • Mentor junior team members and support process optimization initiatives.

Qualifications:

  • 11+ years of clinical data management experience (7+ years in oncology preferred).
  • Expertise in managing external data sources (labs, biomarkers, etc.) in clinical trials.
  • Experience with sFTP, Data Transfer Automation, and vendor management.
  • Strong knowledge of GCP, FDA/ICH guidelines, and EDC systems.

If you have experience managing external data for oncology clinical trials, apply now!

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