Review and provide input on the development of other essential clinical study documents related to clinical data management, clinical statistics, site management & monitoring, clinical safety management, clinical product management, and clinical supplier management. * Perform study- and/or site-level audits of the Trial Master File (TMF) to ensure that study files are current, accurate, complete, and audit-ready. * Oversee study- and site-level management of the Clinical Trial Management System (CTMS) to ensure that study and site details are current, accurate, and complete. * Interact with and/or oversee interactions with investigational sites, vendors, key opinion leaders (KOLs), and consultants. * Coach and ensure successful and effective relationships between study teams and investigational site personnel. * Conduct site management & monitoring, clinical product management, and clinical ...
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