Shay Brill

Central Lab Project Manager Consultant @Gates Medical Research Institute

Cambridge, MA, US

Working with the Central Laboratory Operations Lead and clinical team members to establish the scope of work for the central lab on a particular program/study-Managing study lab budgets on an ongoing bases, including work order execution, invoice review, and change order management-Providing oversight to the development of project plans and timelines with the central laboratory-Working with the central laboratory leadership and/or Central Laboratory Operations Lead to provide effective solutions to challenges that arise during a study-Overseeing the preparation of the central lab related study documentation such as central lab specifications, lab manual and clinical site lab training documents-Provide training to the Clinical Trial team, including CRAs (internal & CRO based) on the lab manuals-Driving operational oversight of the life cycle of clinical samples (collection, sample tracking, processing, analysis, data delivery, cleaning process, and final sample disposition-Overseeing sample tracking and logistics for clinical samples prior to long-term storage, including query/discrepancy resolution, by working closely with the clinical trial manager, data management, central laboratories, and specialty lab vendors- Contributing to data transfer agreements for lab data and supporting the Clinical Data Management team during data cleaning to ensure oversight of clinical samples, data transfer, and reconciliation procedures-Providing input on eCRFs pertaining to safety and diagnostic samples-Representing Clinical Laboratory Operations cross-functionally by attending clinical trial meetings, performing eTMF submissions and reviews, and leading lab issue escalations in collaboration with the Central Lab Operations Lead-Providing oversight and coordination of the operational aspects of the functional areas on assigned projects to ensure compliance with ICH guidelines, GCLP, applicable regulatory guidelines, and laboratory procedures.

University of Virginia

Bachelor's degree, Medical Technology Program

The George Washington University

Masters of Science in Health Sciences, Clinical Research Administration

University of Mary Washington

BS, Medical Technology