Biomarker Operations and Sample Management Specialist - SciPro : Job Details

Biomarker Operations and Sample Management Specialist

6mth contract (extension + FTE available)

Onsite - Redwood City, CA

Playing a critical role within Translational Medicine function, the position will be providing biomarker operational expertise in, developing scope of work, and maintaining effective working relationships with cross-functional teams for phase three clinical trials.

Responsibilities:

• Operationalize the CDx strategy to support early and late-stage development of portfolio assets.
• Effectively collaborate with biomarker scientists and clinical operations to ensure successful collection and CDx testing of clinical trial samples.
• Collaborate with diagnostic partners and internal cross-functional team members to ensure successful management of CDx samples.
• Work closely with Clinical operations group for central lab set up, including kit design, sample processing instructions and logistics.
• Work closely with biomarker scientists to oversee development of the scope of work, budgets, and timelines by CROs.
• Assist in sample reconciliation between central labs and biomarker vendors/CROs.
• Perform day-to-day operational management of CROs to ensure timely delivery with high standard of quality.
• Provide sample and assay status updates to biomarker and diagnostic sub-teams.

Education, Experience, and Skills:

• BS or MS and 3+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotech R&D environment.
• Prior experience in clinical biomarker operation and/or sample management required (Phase III desirable)