Duties: Responsible for providing timely and professional ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data and ensuring their resolutions in order that databases can be declared clean and locked according to strict performance standards. Review and contribute to the development of trial validation plan related documents and create/approve final CRF design, validation checks and reports necessary to assure high quality and consistent data. Review and contribute to the preparation of protocols, CRF's and prepare or review/contribute to operations manuals. Organize / chair data management meetings. Support and assist clinical data managers, clinical data assistants for allocated trials. Work very closely with Contract Research Organizations (CROs) contracted to perform data management functions. Support and assist with lab data review, SAE reconciliation, third party data reconciliation. All other duties as assigned. Skills: Pharma Industry Experience 3 years experience in clinical data management Education: BA/BS ()
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