Yoh has a contract opportunity for a Biosample Operations Manager to join our client in South San Francisco, CA.
- The Biosample Operations Manager (BOM) plans and coordinates all operational activities required throughout the whole lifecycle of samples, including collection, processing, analysis, data transfer, and final repository of non-safety samples within a clinical study.
- The BOM is simultaneously assigned to multiple studies and is an SMT member for each.
- BOM provides sample management expertise and may also participate in Biomarker and Pharmacology teams.
- In addition, the BOM is accountable for ensuring that samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent.
- The BOM is the primary interface for operational activities between the SMT and laboratories performing biomarker or PK analysis.
- Accountable for planning, organizing and overseeing the collection and shipping of biosamples from investigator sites or Central Labs and their subsequent delivery to assay laboratories to ensure timely delivery and optimal analyzable quality.
- Accountable for biomarker and PK samples and any other samples deemed by the Personalized Healthcare Leader (PHCL) and/or Sr. BOM/BTAL to require special oversight.
- Accountable for accurately forecasting and tracking study biosample costs related to materials, logistics and shipping when the CSO (Clinical Sample Operations) is the point of first receipt for the samples.
- Give input to assessment of site feasibility for relevant sample collection 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 meeting and drive decisions on sample collection, kit design and sample shipping schedule.
- 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.
- Provides the day-to-day operational management of CROs (i.e. central lab, etc.) and biomarker assay vendors to ensure delivery against contracted scope of work, including coordination of scope of work development, performance management, and issue resolution.
- Oversee vendors for the duration of the contract to ensure samples are received, assayed, and data is reported according to study timelines.
- Review and approval of invoices (as needed) in the financial systems to ensure appropriate work has been completed prior to payment.
- Life sciences degree.
- Proven clinical development experience of working in teams running clinical studies, monitoring clinical studies or experience of working in clinical studies at an investigator sites.
- Proven clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples.
- Proven critical reasoning skills including the identification and resolution of complex problems.
- 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 and presentation skills.
- Proven effective influencing skills.
- Proven ability to build and maintain effective working relationships.
- Vendor Management experience advantageous.
Discover all that's possible with Yoh. Apply now.
Recruiter: Salima Hakim
Yoh is a professional staffing provider with over 70 years of experience in the short and long-term staffing services industry; visit our website to learn more about our company. If you are seeking workforce solutions in the IT sector, see our comprehensive IT Staffing Resources.
Yoh, a Day and Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
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