Roles and Responsibilities:

• 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...