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Jess Vicari is an accomplished professional in clinical operations and trial master file (TMF) management, currently serving as Senior Director of TMF Operations and Clinical Systems at Sage Therapeutics since June 2022. With extensive experience in the life sciences industry, Jess has previously held key roles at Gilead Sciences, Immunomedics, Advanced Clinical, and Syneos Health, focusing on electronic clinical systems, compliance, and quality within clinical development. Jess has a strong background in developing business processes, implementing eTMF solutions, and ensuring compliance with regulatory standards. Jess holds a BA in Behavioral Science from Drew University and has contributed to numerous organizations through leadership, project management, and process optimization expertise.