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Associate External Data Management Director

Exelixis • Alameda, CA, US • published 2026-10-08 09:03:35.787388

Description

The Associate External Data Management Director is responsible for managing the processing of external and/or local lab data received by Exelixis throughout the clinical trial lifecycle. They provide subject matter expertise in external data handling of various external data sources (ie: central laboratories, pharmacokinetic, immunogenicity, pharmacogenetic and biomarker samples, etc.) to internal cross\-functional teams and external stakeholders to ensure high quality data. They provide support to the Lead Data Manager (LDM), Clinical Operations as well as the Biosamples managment group with the review, maintenance, and management of external vendor. Leads functional service provider resources in a matrixed environment. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** * Develop and maintain strong, collaborative relationships with internal study execution/management teams, CROs, laboratory service providers, and other key stakeholders. * Develop the Data Transfer Plan (DTP), including the Data Quality Review reconciliation section for the external vendor data transfer(s), obtain final approvals and file document to the Trial Master File (TMF) as applicable. * Develop and document extern...

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