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Job Details

Biosample Clinical Operations Lead

Boston, MA, United States

Posted on
Jul 12,2019

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Job Description:
**MEMBERS ONLY**SIGN UP NOW***. Pharmaceuticals is seeking to recruit a Biosample Operations Lead in support of the company's clinical research in rare diseases.

Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (oversight of sample collection at site, shipment to vendor for testing/processing, analysis and final sample disposition).
Collaborate with study teams and the biomarker group to develop biological sample management plans in concurrence with sites, central and other Laboratories for all biomarker samples.
Review clinical study protocols, informed consents, laboratory documents, case report forms, and service provider laboratory scope of work documents for sample handling details.
Work closely with study teams to manage monitoring of appropriate patient consent for all biosample collection and testing.
Ensure compliance with European GDPR requirements for personal information transmitted with biosamples.
Interface with laboratory personnel, sample processing vendors, and other vendors as needed to ensure proper shipment of samples, respond to issues as needed, and ensure study objectives for clinical biosamples are met.
Ensure sample integrity and maintain GCP compliance for samples through chain of custody, sample handling guidelines, and proper storage conditions.
Responsible for documentation, SOPs and protocols related to clinical samples.
Participate in process improvement projects (SOPs, Work Instructions, training materials) under the direction of Manager.
Bachelor's degree in Biochemistry, Chemistry, Biology, Immunology, Medical Technology or related field is required
Excellent knowledge of clinical trials and understanding of the role of biomarkers in clinical studies
Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling.
Experience working in a laboratory is ideal
Proven critical reasoning skills including the identification and resolution of complex problems
Ability to manage and vet sample vendors and oversee sample management activities across multiple projects
Excellent written, organizational and interpersonal communication skills necessary to interface with outside vendors, consultants, and internal team members
Technical knowledge to maintain electronic files and experience with database entry (e.g. LIMS).
Proficiency in Microsoft Office Applications including Excel, Word, and PowerPoint
Works successfully under pressure with tight timelines
Demonstrated ability to collaborate with a diverse group of scientists, clinicians, vendor labs, and a variety of internal and external team players to support product strategy
Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling.
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