eCRF Design - Able to critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards. Recognizes limitations in eCRF design and works with the study team to correct flaws proactively.
SDTM Conformance Mapping Create and Reviews SDTM conformance mapping specifications applying SDTM, TAUG and Client standard.
CDISC Validation Tools - Executes validation tools (e.g., Pinnacle 21) and collaborates with other functions to resolve identified issues. Ensure any unresolved issues are appropriately documented (e.g., Clinical Study Data Reviewer's Guides).
Create and review Trail Design domains
Clear understanding of End-to-end traceability from Data Collection to Data reporting.
Metadata Repository - Responsible for managing libraries of CDISC-related metadata, terminology, and rel...