Job Description
Remote
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 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 related standards within the metadata...
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 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 related standards within the metadata...
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