Biosample Operations Manager


South San Francisco, CA

What you'll be doing

Accountable for planning, organizing and overseeing the collection and shipping of biosamples from investigator sites or centralized locations and subsequent delivery to assay laboratories to meet timelines. Provide input during protocol and ICF development to ensure logistical feasibility of biological sampling and alignment with ICH/GCP, appropriate policies, procedures, and sample testing plans. Ensure sampling information is appropriately collected for tracking and informed consent reconciliation. Accountable for accurately forecasting and tracking study costs associated with biomarker and companion diagnostic assays, sampling materials, logistics & shipping as needed. Give input to assessment of site feasibility for relevant sample processing, collection, storage and shipping to ensure sites can meet sample-handling needs of the study. Determine timelines and request the type of internal resource needed for all biosample operational activities, ensuring these are included in study plans and are appropriately tracked. Organize and lead the cross-functional sample and data handling or other stakeholder meetings to drive decisions on sample collection, kit design, shipping schedule, and data deliverables. Write the biosample management plan (BMP), a functional deliverable to the SMT, to document cross-functional agreements on the lifecycle and reconciliation plan for each sample type and contribute to the development of biomarker-related plans. Accountable for ensuring suitable sample handling training and sample collection and processing reference material are provided to the investigator sites, study monitors/CRO partners. Deliver presentations and trainings at investigator and monitor meetings. Accountable for providing answers to questions from ethics committees with regard to repository samples and roche policies.

What your background should be

The candidate should have experience in related field. Proven clinical development experience working in teams running clinical studies, site monitoring or working in clinical studies at an investigator site. Detail oriented with the ability to work independently and manage multiple competing priorities. Proven ability to work successfully under pressure. Proven planning, organizational, and time management skills. Proven ability to successfully achieve results within a multi-cultural and geographically diverse team. Proven effective communication, influencing, and presentation skills. Proven ability to build and maintain effective working relationships.

Required Schooling / Training

Life sciences degree or equivalent.

Who is the client company

This is a biotechnology corporation.
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