“Gabriela Gottlieb is the Supervisor of Clinical Operations at Fujirebio Diagnostics where she drives operational activities related to the implementation of Clinical Risk Management, Clinical Issue Management, and Clinical Trail Management Systems across the Clinical R&D department. In this capacity she interacts with executive level management, external vendors, collaboration partners, clinical study and other internal personnel to ensure compliance with regulations, Fujirebio business practices and clinical research program objectives. Prior to 2018, Gabriela served in a variety of roles in Medical Device Orthopedics and Cardiovascular Manufacturers. She has a track record of implementing quality systems in Clinical Research and Regulatory Affairs. She has authored multiple regulatory submissions and has led several regulatory inspections with FDA, EMA and other global regulatory bodies. She bases her approach to program implementation through change management principles with a focus on data integrity and quality.”
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