External Data Management Lead – Clinical Trials

Exelixis Inc; Alameda (CA); On-site; USD 160,000 - 227,000; Full time

Benefits offered by this job

401k Plan

Medical Insurance

Dental Insurance

Vision Insurance

Stock Options

Annual Bonus

Vacation + Holidays

Sick Days

Job summary

Exelixis Inc. seeks an Associate External Data Management Director to oversee processing of external and local lab data across the clinical lifecycle. You will partner with internal teams, CROs, and vendors to ensure high-quality data and efficient transfer workflows.

The role requires extensive clinical data management expertise, strong project leadership, and deep knowledge of GCP/FDA regulations. A focus on oncology biomarker data and eCRF design will be important in this position.

Qualifications

• Minimum of 11 years of related experience; or 9–11 with advanced degrees.
• Clinical or biological lab data handling and oncology biomarker familiarity.
• Experience in oncology trials and data management leadership required.

Responsibilities

• Develop and maintain strong relationships with study teams, CROs, and labs.
• Develop Data Transfer Plan and QA/UAT for external data transfers.
• Create external data edit checks, reports, and QC processes.
• Lead cross-functional vendor management in a matrixed environment.
• Review vendor SOWs and ensure protocol parameters are captured.
• Mentor junior staff and provide guidance across projects.

Skills

Clinical data management

Data transfer automation

Vendor management

Project leadership

GCP/FDA knowledge

EDC systems

Communication skills

Education

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

Tools

EDC systems

CDISC/CDASH

SAS

MS Office

Job description

Exelixis Inc. seeks an Associate External Data Management Director to oversee processing of external and local lab data across the clinical lifecycle. You will partner with internal teams, CROs, and vendors to ensure high-quality data and efficient transfer workflows.

The role requires extensive clinical data management expertise, strong project leadership, and deep knowledge of GCP/FDA regulations. A focus on oncology biomarker data and eCRF design will be important in this position.