Job Description

Director, External Data Management

Location: San Francisco Bay Area or Greater Philadelphia Hybrid | Full-Time | Biotech Sponsor-Side Role

I'm currently partnered with a biotech client seeking a Director of External Data Management (EDM) to lead critical data integration functions for their clinical development programs. This is a strategic and operational leadership role, responsible for overseeing external and local lab data across early to late-phase oncology trials.

About the Role:

The EDM Director serves as the key point of contact for vendor data integration, leading planning and reconciliation efforts across various lab and biomarker data streams. You’ll work cross-functionally with Clinical Operations, Biosample Management, and Data Science teams while partnering closely with CROs and lab providers.

Responsibilities:

• Lead end-to-end oversight of external data processes (including PK, biomarker, genomic, and lab data) across the clinical trial lifecycle
• Develop Data Transfer Plans (DTPs) and data edit check strategies, and ensure high-quality vendor deliverables
• Collaborate with internal stakeholders and functional service providers to align on expectations, timelines, and compliance standards
• Review vendor statements of work and ensure accurate mapping of protocol requirements
• Manage query resolution, lab range QC, and data issue tracking
• Mentor junior team members and contribute to process improvements and automation initiatives

Qualifications:

• 13+ years of relevant industry experience (clinical or biological lab background preferred)
• 7+ years in clinical data management; 4+ years in project or functional leadership
• 5+ years of experience in vendor oversight and sFTP/data transfer automation
• Strong working knowledge of EDC systems, FDA/ICH/GCP guidelines
• Deep familiarity with oncology terminology and biomarker data in early-phase trials

Why Consider This Role?

This is a chance to drive innovation in a fast-paced clinical development environment, working with cutting-edge data in support of precision medicine initiatives. If you're passionate about data integrity, operational efficiency, and cross-functional collaboration, this role offers the visibility and impact to match your experience.

If you're interested in learning more, feel free to reach out directly or apply here for a confidential discussion.

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