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Biosample Operations Manager IV

Company: Apex Systems
Location: San Mateo
Posted on: November 18, 2020

Job Description:

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 ProtocolICF development and IRBHAEC 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 transferdiscrepancy resolution with Central Lab, Sample Handling and testing groupvendor 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, timelinesmilestones, align on Biomarker Plan and deliverables) Requirements Life sciences degree and a minimum of 4 years working experience in the healthcare and biopharma 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 andor 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. EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or

Keywords: Apex Systems, San Mateo , Biosample Operations Manager IV, Other , San Mateo, California

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