Astellas Gene TherapiesClinical Trial Specialist
Jul. 2020 - Apr. 2021San Francisco, California, United States- Manage sites in maintenance of supplies necessary for trial conduct. - Assembles and performs first pass review on study start-up documents and RAF/EAF under the guidance of the study lead. - Independently maintain the internal Trial Master File (TMF) in accordance with the DIA’s reference model and periodically review the TMF(s) to ensure accuracy, completeness and adherence to the TMF filing plan - Support clinical trial manager in overseeing trial laboratories/sample management plans and activities - Support clinical trial managers in development, multi-functional review and finalization of study documents relevant to execution - Act as primary point of contact for specific trial related vendors as assigned Assist with clinical data review, data reconciliation, query follow up/tracking under the direction of the clinical trial manager