Clinical Data Standard Associate. -SDTM

Cognizant Technology Solutions Corporation; Hyderabad, Chennai, Bengaluru; On-site; INR 1,100,000 - 1,500,000; Full time

Job summary

Cognizant is seeking an SDTM Profile Associate to support development, review, and finalization of SDTM deliverables for regulatory submissions. The role emphasizes hands‑on experience with annotated CRFs (aCRF), SDTM specification creation, Pinnacle 21 validation, define.xml, and cSDRG development.

Location: PAN India. Collaborate with biostatistics, clinical data management, and regulatory teams to ensure CDISC compliance and timely milestones.

Qualifications

• Hands-on experience with annotated CRFs, SDTM specification creation, and cSDRG development for regulatory submissions.
• Proficient in SDTM domain mapping, variable metadata, and controlled terminology application.
• Experience with P21 validation checks and resolving findings before milestones.

Responsibilities

• Create and review annotated Case Report Forms (aCRF) aligned with SDTMIG standards.
• Develop and maintain SDTM specifications, including domain mapping and metadata.
• Perform Pinnacle 21 validation checks and address findings before milestones.
• Prepare and finalize define.xml files ensuring accurate metadata representation.
• Author and review the cSDRG, summarizing dataset conformance and data considerations for regulators.
• Collaborate with biostatistics, data management, and regulatory teams to ensure consistency across submissions.
• Support regulatory submissions by ensuring SDTM datasets meet CDISC and regulatory requirements.
• Track CDISC standard updates and internal SOPs.

Skills

Annotated CRFs (aCRF)

SDTM specifications

Pinnacle 21 validation

Define.xml development

cSDRG development

CDISC standards

Tools

Pinnacle 21 (P21)

CDISC Define-XML tooling

Job description

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