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.

We are looking for Graduates/Post Graduates (preferably Life Science) with 2 to 10 years of Work Experience in Clinical domain (CDM Clinical Trials) with good experience in Standard data tabulation module (SDTM) and Clinical Data Interchange Standards Consortium (CDISC).

Candidates should have good communication skills and Willingness to work in shifts.

For any clarifications feel free to contact.

Adarsh,

adarsh.pb@accenture.com

+918040777026