External Data Management Lead – Clinical Trials

Exelixis, Inc.; Alameda, Northern (CA, KY); Hybrid; USD 160.000 - 227.000; Vollzeit

Benefits dieser Stelle

401k plan

Medical/Dental/Vision

Stock options

Vacation and holidays

Zusammenfassung

Exelixis, Inc. is seeking an Associate External Data Management Director to oversee processing of external and local lab data across the clinical trial lifecycle.

You will provide subject matter expertise on external data handling for multiple data sources and support internal teams and external stakeholders to ensure high quality data. You’ll develop data transfer plans, edit checks, and QC processes, while guiding a matrixed team and coordinating with CROs, labs, and vendors to meet project

Qualifikationen

• Clinical or biological laboratory experience with focus on processing/analyzing samples.
• Familiarity with oncology terminology and genomic biomarker endpoints is essential.
• Experience with FDA/ICH/GCP regulations and guidelines is required.
• Minimum 11 years of related experience; 7+ years clinical data management; 4+ years leadership.

Aufgaben

• Develop and maintain external data transfer plans and data quality review reconciliations.
• Lead vendor data management activities and QC/QA of external data.
• Collaborate with CROs, labs, and other stakeholders to meet study milestones.
• Mentor junior team members and manage multiple external data projects.

Kenntnisse

Project Management

GCP knowledge

CDISC standards

Vendor Management

EDC experience

Data Transfer Automation

Ausbildung

BS/BA degree

MS/MA degree

PhD degree

Equivalent combination

Tools

sFTP

EDC software

Trial Master File systems

Jobbeschreibung

Exelixis, Inc. is seeking an Associate External Data Management Director to oversee processing of external and local lab data across the clinical trial lifecycle.

You will provide subject matter expertise on external data handling for multiple data sources and support internal teams and external stakeholders to ensure high quality data. You’ll develop data transfer plans, edit checks, and QC processes, while guiding a matrixed team and coordinating with CROs, labs, and vendors to meet project