Understand the usage of CDISC SDTM Guidance rules to annotate eCRFs with SDTM domains and variables.
Identify the required SDTM domains required based on CRF data
Identify the standard SDTM domains and assign to CRF
Identify the protocol specific SDTM domains and assign to CRF
Define the QC & Validation of SDTM mapping
Take complete ownership of quality of deliverables, training needs, sharing best practices with the team and act as s Subject Matter Expert
Coordinate with Quality control lead & Data Mapping Team Lead to ensure high quality on deliverables
Ensure Unit testing, peer review, and code reviews on time with appropriate quality
Make visible improvements in SDTM (Mappings, Deployments, Spec/Define) quality and exhibit an upward trend in Quality improvements
Develop and champion project specific Domain (SDTM/Deployment etc)/Functional/Technical knowledge (SQL, UNIX, TTR code optimizations, Shell Scripts etc)
Proactively identify the training/skills required for the project. Assess the current skill level/ required skill level for the project and close the gaps
Identify the technical skill gap in the team and conduct technical training session for them. |