Cognizant is hiring for the position of Clinical Data Standard Associate – SDTM for candidates with 5–10 years of experience. The role focuses on developing, reviewing, and finalizing Study Data Tabulation Model (SDTM) deliverables in accordance with CDISC standards and regulatory submission requirements.
The position requires hands-on experience with annotated Case Report Forms (aCRF), SDTM specifications, Pinnacle 21 validation, define.xml, and clinical Study Data Reviewer’s Guide (cSDRG) development.
Job Details
| Particulars | Details |
|---|---|
| Company | Cognizant |
| Job Title | Clinical Data Standard Associate – SDTM |
| Experience | 5–10 years |
| Job Locations | Hyderabad, Chennai, Bengaluru |
| Work Mode | Hybrid |
| Job Location Scope | PAN India |
| Openings | 1 |
| Application Email | sanjuna.nekkanti@cognizant.com |
Position
Clinical Data Standard Associate – SDTM
The selected candidate will support the development, review, and finalization of standardized clinical trial data deliverables for regulatory submissions.
Roles and Responsibilities
- Create and review annotated Case Report Forms (aCRF) in accordance with SDTM Implementation Guide (SDTMIG) standards.
- Develop and maintain SDTM specifications, including domain mapping, variable-level metadata, and controlled terminology.
- Perform Pinnacle 21 (P21) validation, analyze validation reports, and resolve or document errors, warnings, and notices.
- Prepare and finalize define.xml files covering dataset metadata, variable metadata, value-level metadata, and codelists.
- Develop and review the clinical Study Data Reviewer’s Guide (cSDRG), documenting dataset conformance, deviations, and study-specific considerations.
- Collaborate with biostatistics, clinical data management, and regulatory affairs teams.
- Support regulatory submissions to agencies such as the FDA and PMDA.
- Implement updates based on CDISC standard releases, regulatory guidance, and internal SOPs.
Eligibility and Qualifications
Candidates should have 5–10 years of experience and hands-on expertise in SDTM deliverables and documentation for regulatory submissions.
Relevant experience includes:
- Annotated CRF (aCRF) development and review.
- SDTM specification creation and maintenance.
- Pinnacle 21 validation and issue resolution.
- define.xml preparation and finalization.
- Clinical Study Data Reviewer’s Guide (cSDRG) development.
- Compliance with CDISC standards and regulatory requirements.
Required Skills
- Study Data Tabulation Model (SDTM)
- CDISC standards and SDTMIG
- Annotated Case Report Forms (aCRF)
- SDTM mapping and specifications
- Pinnacle 21 (P21) validation
- define.xml development
- Clinical Study Data Reviewer’s Guide (cSDRG)
- Controlled terminology and metadata management
- Regulatory submission support
- Cross-functional collaboration
Application Details
Interested candidates can share their resume and the required details with Cognizant at the email address below.
Email: sanjuna.nekkanti@cognizant.com
Subject suggestion: Application – Clinical Data Standard Associate – SDTM
