Senior Clinical Programmer (SDTM)

+ 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, 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 needed.

+ Support the develop...

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