Job Description
Review and provide input into all trial set-up documentationTranslate protocol and any applicable de-risking into the creation and maintenance of detailed technical specifications, mapping documentation including aCRF, data transfer agreements, as applicable, etc.Creation of Data Review Model (DRM) based on current Client standards and SDTM datasets based on current SDTM standardsCreation of back-end edit checks, listings, and visualizations to support risk-based central monitoring, e.g., Quality Tolerance Limits (QTLs), Critical to Quality (CtQ), etc., and ongoing clinical and safety data reviewQC of all clinical programming deliverablesPerform unblinding, data-cut activities for planned reporting milestones and database locksDevelopment and validation of electronic submission packages that comply with submission requirements from FDA, EMEA, and other regulatory agencies as needed.Support the development of standards a...