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