Managing phase I (FIH) Oncology studies in Rave EDC & SAS Drug Development environment. Delivering PowerPoint, protocol-specific presentations. Responsibility include but not limited to protocol review, external vendors data transfer agreements review, DMP, DRP, and other DM related documentation writing and updating. Full cycle data base design in CDASH/SDTM standard; from initial protocol to go-live date. Managing external vendors (Lab, ECG, PK, IVRS etc), performing quality control and assurance of all vendor data. Using SAS Drug Development environment to QC metadata as well as EDC data. Overseeing all DM CRO activities. Responsible for VTMF data filing & maintaining 100% audit readiness. Serve as liaison between the vendors, sites, monitors and DM CRO. Delivering SDTM datasets to statistical programming for interim locks or interim data reviews. Reporting to upper management on study progress, timelines & overall status.