• Create and/or review study-specific electronic or paper Case Report Forms (CRFs) using prior knowledge, protocol-specific information, and departmental standards. • Work efficiently to incorporate core clinical team input and produce CRFs in a timely manner. • Configure, migrate, and test electronic data capture (EDC) databases based on internal procedures, study requirements, and system best practices. • Serve as a database manager for the study-specific clinical team, including the compilation of edit checks. • Develop database requirements for use by EDC vendors. • Serve as a study database manager and work with vendors to obtain deliverables in a timely manner. • Create and/or review study-specific data management and database documentation, which may include: Data Management Plan CRF Completion Guidelines Coding Guidelines Annotated CRFs Edit Check Specifications. • Attend study-specific team meetings and produce status reports and requested metrics, which may include query information or data trends. • Perform data review and query generation/closure. • Perform coding of verbatim terms such as adverse events and concomitant medications. • Collaborate with medical scientists for coding, consistency, review, and approval. • Incorporating coding files into the clinical database. • Participate in the development of new processes or revision of existing processes. • Train internal colleagues in clinical data management in either informal or formal settings as needed. • Train Investigators and/or Study Coordinators at Investigator Meeting on the CRFs, the EDC system, and the CRF completion guidelines as needed. • Provide data management expertise and support to the clinical teams using data management best practices. • Provide analytical insight into data management strategies and advise the internal team with tactical strategies accordingly. • As necessary, provide work direction, guidance, mentoring, influence, and support to junior staff. • Train junior staff in more complex clinical data management processes. • Adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates. • Perform ad-hoc and cross-functional projects assigned to support business needs and provide developmental opportunities.