Job Description

  • 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 development of standards a...

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