Perform or provide oversight to staff for all CDM activities from study startup to archival: design CRFs/eCRFs, create Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHODrug; and complete data base lock, archival, and closeout activities. Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures, CDASH and SDTM data formats.