External Data Management Associate – Lab Data & Vendors

Exelixis

Alameda (CA)

On-site

USD 160,000 - 227,000

Full time

7 days ago

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Benefits offered by this job

401k plan

Medical, dental, vision insurance

Life and disability insurance

Stock purchase program

Discretionary annual bonus

Vacation and holidays

Job summary

Exelixis is seeking an Associate External Data Management Director to oversee processing of external data across the clinical trial lifecycle. The role provides SME guidance on external data sources and leads vendor relationships to ensure high-quality data for internal teams and stakeholders.

Responsibilities include developing the Data Transfer Plan, external data edit checks, and collaboration with CROs and study teams.

Qualifications

Clinical or biological laboratory experience focusing on processing/analyzing samples.
Familiar with oncology lab terminology and genomic biomarker endpoints.
Strong knowledge of FDA and ICH/GCP guidelines.
Extensive CDM experience in pharma/clinical trials, including oncology.
EDC experience required.

Responsibilities

Develop and maintain relationships with internal teams, CROs, labs, and stakeholders.
Develop Data Transfer Plan (DTP) and file TMF documentation.
Create external data edit checks, reports, and perform QC/UAT.
Collaborate with external provider counterparts on milestones and deliverables.
Review vendor SOW for study scope and ensure parameters are included.
Ensure external data transfers meet protocol parameters and populate correctly.
Review discrepancies and manage queries to resolution.
Mentor junior team members and provide guidance.
Participate in protocol reviews and eCRF design as needed.
Plan and manage multiple external data projects and report progress.