Lead Clinical Data Manager
Current• Directed and represented clinical data management during internal cross-functional meetings and external meetings including investigator’s, bid defense, and vendor evaluation meetings. • Oversaw the CRO and external vendors for outsourced studies as required. • Analyzed and outlined study requirements with respect to Clinical Data Management and ensured end-result met the study requirements based on clinical and submission point of view.• Ensured the study database met ICH/GCP guidelines and adhered with CDISC standards (CDASH and SDTM) and followed Good Clinical Data Management Practice (GCDMP). • Introduced process improvements and streamlined data management processes, as well as formulated SOPS.• Evaluated database development including CRF/eCRF design, edit checks programming, EDC reports, central/local lab configuration, coding dictionaries management, EDC configuration, and administration (user access control, license maintenance, system support, and training) in the iMedNet EDC system. • Led the creation of DMP, edit check specification (ECS), CRF completion guidelines (CCG), data validation plan (DVP), UAT plan, UAT summary report, and DTA. • Led UAT execution, study conduct/post-production support, external data and SAE reconciliation, manual cleaning process, SAS reports and listings programming, Database Lock, and SDTM conversion. • Prepared a snapshot for DMC/DSMB charter, reviewed SAP and supported TLFs for interim and final analysis and supported protocol & CSR review with respect to DM’s perspective. • Led the DM activities in collaboration with a high performing, cross-functional study team including clinical science, biostatistics and statistical programming, clinical operations, project management, and pharmacovigilance. • Collaborated with project managers on clinical trial start-up activities (review of RFP, SOW, CRO and vendor selection, preferred EDC system selection, and cost estimation).
