• Provide operational leadership to the direction, design, planning, execution, collection and handling of all clinical data to the highest quality standards • Coordinates and participates in the review of clinical data, including support for data review systems, development of processes and guidelines, and production of custom database reports • Ensure the quality of clinical data within EDC systems at the time of database snapshots and database locks, including definition, documentation and management of all processes related to database snapshots and locks • Work closely with CROs to prepare and ensure proper development and execution of data management activities • Review protocols to ensure database feasibility • Provide effective oversight of all CRO data management related deliverables • Ensure that eCRFs, database interfaces, programmed edit checks and external data files, CRF completion guidelines are designed and built in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and regulatory submissions • Collaborate with Biostatistics and Statistical Programming to develop data review standards and tools, including visualization tools if needed • Work collaboratively with Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data in timely fashion. • Responsible for documentation and archival standards for Data Management deliverables including systems, databases, programs, and specifications, and ensures DM project documentation is in an audit-ready state • Ensure that all clinical trials have complete and accurate supporting documentation for regulatory submission including raw datasets and bookmarked, annotated CRFs • Responsible for development, maintenance and governance of CDM standards (standard eCRFs, CDASH, etc.) • Ensure that data management activities are conducted in accordance with GCP, GCMP, internal SOPs and all regulatory requirements