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Biosample Operation Manager

Company: Millipore Corporation
Location: Billerica
Posted on: January 13, 2021

Job Description:

Your role:The Biosample Operations Manager (BOM) will act as the SME for all biological samples collected during the clinical trial. You will be--responsible for the Biosample operational implementation and execution of the translational medicine strategy (e.g. Biomarker/CDx, PK, ADA) in an assigned clinical trial. You will also maintain--a patient focus to balance the value of samples versus the complexity of collection, cost to the trial and potential affects upon patient recruitment and burden. You will be--responsible for overseeing the business process of Biosample lifecycle to ensure that the samples are collected, processed, analyzed and stored with the highest degree of quality and according to applicable regulations. You will--review--and provide--input regarding operational feasibility for relevant clinical documents and/or answering regulatory questions concerning operational activities. You'll--act--as single point of contact regarding all Biomarker/PK/ADA operational aspects within the Clinical trial team. You will--manage--the interface between GCO, non-GCO functions and External partners (e.g. CRO, Analytical Labs) to ensure proper planning and cross-functional alignment on deliverables and timelines.Who you are:Minimum Qualifications:* Bachelor's degree in Biology, Pharmaceuticals or other Science discipline with 3+ years of experience in clinical operations, or Master's degree in Biology, Pharmaceuticals or other Science field* Excellent command of English language (verbally and in writing); other language(s) is a plusPreferrred Qualifications:* PhD in Biology, Pharmaceuticals or other Science discipline strongly preferred* 4+ years clinical operations experiences and a minimum of 2+ years experiences with clinical Biomarker/Biosample processes* Certification in Clinical Research or Bachelor or Masters' degree in Clinical Research/Clinical Trial Management

Keywords: Millipore Corporation, Billerica , Biosample Operation Manager, Executive , Billerica, Massachusetts

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