Clinical Data Standard Associate. -SDTM

Job Summary

SDTM Profile Associate to support the development, review, and finalization of standardized clinical trial data (SDTM) deliverables in accordance with CDISC standards. The ideal candidate should have hands-on experience with annotated CRFs (aCRF), SDTM specification creation, Pinnacle 21 (P21) validation, define.xml, and clinical Study Data Reviewer's Guide (cSDRG) development for regulatory submissions.

Roles and Responsibilities

• Create and review annotated Case Report Forms (aCRF) in line with SDTM Implementation Guide (SDTMIG) standards.
• Develop and maintain SDTM specifications, including domain mapping, variable-level metadata, and controlled terminology application.
• Perform Pinnacle 21 (P21) validation checks, analyse validation reports, and resolve/document findings (errors, warnings, and notices) prior to milestones.
• Prepare and finalize define.xml files, ensuring accurate metadata representation of datasets, variables, value-level metadata, and codelist
• Author and review the clinical Study Data Reviewer's Guide (cSDRG), summarizing dataset conformance, deviations, and study-specific data considerations for regulatory reviewers.
• Collaborate with biostatistics, clinical data management, and regulatory affairs teams to ensure consistency across submission deliverables.
• Support regulatory submissions (e.g., FDA, PMDA) by ensuring SDTM datasets and associated documentation meet current CDISC and regulatory agency requirements.
• Track and implement updates based on CDISC standard releases, agency guidance, and internal SOPs.

Location: PAN India

Note: Interested candidates can share their resume & below details to [email removed]

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Regards

Sanjuna N

Talent Acquisition Group

Cognizant