Senior Clinical Programmer (SDTM)

Responsibilities

• Review and provide input into all trial set‑up documentation
• Translate 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 standards
• Creation 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 review
• QC of all clinical programming deliverables
• Perform unblinding and data‑cut activities for planned reporting milestones and database locks
• Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA, and other regulatory agencies as need...