









Provides administrative support and assists with medical management project delivery activities. Performs data entry, creation and maintenance of files, spreadsheets, and reports. Core Responsibilities • Performs Trial Master File (TMF) filing of study specific medical documents and relevant medical communication; may participate in TMF file audits. • Assists Medical Management and Scientific Services staff with eligibility review and project management activities, including developing of eligibility review forms and other study related documents as needed. • Supports medical review query management and other medical data review tasks as needed. • Manages shared mailbox and routes correspondence appropriately. • Assists with coordination of medical management project meetings, attends meetings, prepares meeting minutes and action items, and maintains study -related documents. • Uploads and manages documents collected for eligibility review into TrialEASTM and other eligibility review support systems as needed. • Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs), all enterprise policies, standard operating procedures, work instructions, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans