Biosample Operations Manager IV

Employment Type

: Full-Time


: Miscellaneous

Biosample Operations Manager (BOM)Job Purpose: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 vendorsSingle point of contact for status of clinical trial samples and biomarker data* Manage sample transfer/discrepancy resolution with Central Lab, 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)RequirementsLife sciences degree and a minimum of 4 years working experience in the healthcare industryProven clinical development experience working in teams running clinical studies, monitoring clinical studies or experience of working in clinical studies at an investigator siteClinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samplesProven critical reasoning skills including the identification and resolution of complex problemsDetail oriented with the ability to work independently and manage multiple competing prioritiesExcellent verbal, written and presentation skillsProven ability to work successfully under pressureAbility 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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