Job Description

Job Title: Director, Data Management (External Data Focus)

Location: San Francisco Bay Area, CA (Onsite, 5 days/week) - Relocation Assistance Available

Work Status: Visa Sponsorship Available

Overview:

A fast-growing biopharma company is seeking a Director, Data Management (External Data Focus) to lead the oversight and integration of external clinical data sources throughout the trial lifecycle. This position plays a critical role in ensuring accurate, high-quality data from external vendors, including central laboratories and pharmacokinetic (PK) partners, in support of complex oncology and biomarker-driven clinical programs.

Key Responsibilities:

• Provide strategic oversight of external data vendors, with a focus on Central Labs, PK , biomarker, and specialty laboratory data.
• Manage the planning, transfer, validation, and reconciliation of external datasets in collaboration with cross-functional study teams and vendor partners.
• Develop and maintain key study documents such as Data Transfer Plans and edit check specifications.
• Review external vendor deliverables to ensure compliance with protocol, data standards, and regulatory requirements.
• Act as a key liaison between data management, clinical operations, and external partners to support smooth data flow and resolution of issues.
• Review protocol documents and eCRFs from an external data perspective.
• Mentor team members and help implement best practices in external data processes.

Qualifications:

• BS/MS/PhD in a relevant field with 8–13+ years of experience in clinical data management, including at least 7 years in pharma/biotech.
• Minimum of 4 years in a leadership or project oversight capacity.
• Proven experience overseeing Central Laboratory and Pharmacokinetics (PK) vendors for external data.
• Strong understanding of oncology terminology, biomarkers, and lab-based endpoints.
• Experience with EDC systems, data transfer automation (sFTP), and reconciliation.
• Familiarity with FDA/ICH GCP regulations and CDISC/CDASH standards.
• Excellent organizational, problem-solving, and communication skills.

Additional Details:

• Location: Full-time onsite, Monday–Friday in King of Prussia, PA .
• Relocation assistance is available for qualified candidates.
• Visa sponsorship offered.

Job Tags

Similar Jobs