Clinical Data Manager, Oncology is responsible for clinical data management activities for studies and ensuring FDA requirements for quality databases submissions are met. Perform and manage clinical Data Management (DM) activities for in-house and outsourced trials including protocol review, CRF (Case Report Form) development, database set up activities, data validation process (including manual data review of listings), and SAE (Serious Adverse Events) reconciliation, managing local laboratory and external labs and database lock. Represent DM on clinical teams, coordinate deliverables by other functions and/or CRO (Clinical Research Organization) as necessary to achieve DM deliverables. Coordinate with Programming team to provide support to the data review and safety updates (coordinate generation of data review listings, data retrieval to support data review and analysis, SDTM (Study Data Tabulation Model).
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