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 protected]

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Regards

Sanjuna N

Talent Acquisition Group

Cognizant

📌 Clinical Data Standard Associate. -SDTM (Hyderabad)
🏢 Cognizant
📍 Hyderabad