Biosample Operations Manager (BOM)
The Biosample Operations Manager (BOM) plans and coordinates all operational activities required for the collection, delivery and assay of Biomarker Samples (Dx and PD) within a clinical study. The BOM works closely with Scientists to execute exploratory and Companion Diagnostic biomarker strategy. The BOM serves as a single point of contact on Protocol Execution Teams, Biomarker Subteams and with CRO partners on all aspects of Biosample operations.
Primary Responsibilities and Accountabilities:
Operations support for Biomarker Scientists
- Provide input on Protocol/ICF development and IRB/HA/EC questions in alignment with study protocols
- Facilitate Central Lab set up, including sample collection and processing instructions, kit contents, shipping conditions and logistics
- Oversee outsourcing to CROs and vendor management (specialty lab vendors for biomarker assays)
- Manage timelines for sample testing and data transfer with both internal testing labs and external vendors
Single point of contact for status of clinical trial samples and biomarker data
- Manage sample transfer/discrepancy resolution with Central Lab, Genentech Sample Handling and testing group/vendor
- Provide sample and assay status updates (high level metrics provided to Biomarker subteams)
Execution of Biomarker and CDx strategy
- Develop Biomarker Plan with the Biomarker Subteam Leader (outline execution of exploratory and CDx biomarker strategy and testing timelines)
- Lead Biomarker Execution Working Group (review study updates, timelines/milestones, align on Biomarker Plan and deliverables)
- Life sciences degree and a minimum of 4 years working experience in the healthcare industry
- Proven clinical development experience working in teams running clinical studies, monitoring clinical studies or experience of working in clinical studies at an investigator site
- 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
- Excellent verbal, written and presentation skills
- Proven ability to work successfully under pressure
- Ability to work in a multifunctional team environment, interact with a wide variety of internal and external customers and relate effectively to people at all levels of the organization
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Pre Clinical Development