Veronica Bond Email and Phone Number

• Develop and revise data management documentation ensuring input and approval from relevant study team members as per appropriate SOP/SWP.• Develop Case Report Forms (eCRFs) for clinical trials using protocol schedule of assessments & procedures while adhering to standards• Develop Data Validation Specifications (DVS) document against CRFs and based on study team input• Design automated edit-checks and programmed reports to identify missing, incomplete, or inconsistent data.• Code appropriate terms using latest MedDRA and WHO drug dictionaries• Develop EDC trial in Merge based on protocol specifications, including screens, time and events schedule, dynamics, edit-checks etc.• Participate in study kickoff meetings and present Data Management aspects• Participate in study team meeting to discuss relevant aspects of a trial, including status updates, data management metrics, timelines and data delivery expectations• Train internal users, site users and CROs on eCRF completion guidelines• Responsible for providing timely and professional ongoing quality management of clinical trial data by identifying errors and inconsistencies• Ensure timely issue resolution in order to meet strict performance standards.• Perform reconciliation with various external vendors (histopathology, imaging, PK, biomarker, tumor biopsy samples, etc.)• Code appropriate terms using latest MedDRA and WHO drug dictionaries• Participate in project management aspects with external vendors• Responsible for managing data file transfer schedules and able to quickly and correctly diagnose and solve issues• Ensure timely database freeze/lock by following the guidelines established in the Data Management Plan and/or appropriate SOP/SWP