Job Title

Project Role: Data Standards Specialist – SDTM, ADaM & MetadataWork Experience: 8+ years of relevant experience in Clinical Data Standards / Statistical Programming / Clinical Data Management Work location: Any IQVIA office Location in IndiaWork Mode: HybridRole SummaryThe Data Standards Specialist is a Subject Matter Expert (SME) in CDISC SDTM, ADaM, and clinical metadata, responsible for defining, governing, and supporting standards-driven deliverables across studies. The role has a strong focus on aCRF PDF creation, SDTM/ADaM metadata curation, Pinnacle 21 Enterprise (P21E) exception management, and metrics support for Tables, Figures, and Listings (TFLs). This position ensures high-quality, compliant, and traceable data and metadata to support regulatory submissions and downstream analyses. The specialist works closely with Data Management, Statistical Programming, Biostatistics, Medical Writing, and sponsors to drive standardization, efficiency, and inspection readiness.Key Responsibilities1. Data Standards & GovernanceServe as SME for CDISC SDTM and ADaM standards, including metadata and traceability principles.Develop, review, and maintain SDTM and ADaM specifications and metadata aligned with CDISC Implementation Guides and sponsor standards.Ensure consistent interpretation and application of standards across studies and programs.Lead standards governance activities such as standards reviews, impact assessments, and deviation management.2. aCRF PDF Creation & ReviewCreate, review, and maintain annotated CRF (aCRF) PDFs to support SDTM mapping and regulatory submissions.Ensure accurate and consistent annotation of CRFs to SDTM variables, domains, and controlled terminology.Collaborate with Data Management to align aCRFs with database design, CRF versions, and standards updates.Support submission-ready aCRF packages and address reviewer or regulatory queries related to annotations.3. SDTM / ADaM Metadata CurationCurate, maintain, and govern study-level and standards-level SDTM and ADaM metadata.Ensure metadata consistency across SDTM, ADaM, Define.xml, aCRF, and TFLs.Support Define.xml / Define-XML 2.0 creation, review, and validation, with strong focus on metadata accuracy and traceability.Partner with programming and standards teams to enable metadata-driven study builds and automation initiatives.4. Pinnacle 21 Enterprise (P21E) Exceptions ReviewReview, analyze, and manage Pinnacle 21 Enterprise (P21E) validation findings for SDTM and ADaM.Perform exception classification, justification, and documentation in alignment with sponsor and regulatory expectations.Guide teams on resolution strategies for errors, warnings, and notices.Ensure inspection-ready documentation for P21E exceptions and compliance decisions.5. Metrics Support for TFLsSupport the definition and review of standards and study-level metrics related to Tables, Figures, and Listings (TFLs).Ensure strong traceability from SDTM and ADaM to TFLs, including metadata alignment.Collaborate with Biostatistics and Statistical Programming to ensure consistent use of standards-driven metrics.Contribute to dashboards, reports, or summaries that track quality, compliance, and delivery metrics for TFLs.6. Compliance & QualityEnsure datasets and metadata comply with regulatory submission requirements (FDA, PMDA, EMA, etc.).Support audit and inspection readiness activities related to data standards, metadata, and validation.Promote a strong quality mindset across teams, with focus on consistency, reusability, and traceability.7. Cross-Functional CollaborationPartner with Data Management, Statistical Programming, Biostatistics, Medical Writing, and external vendors.Collaborate with sponsors to align on standards, metadata expectations, and submission strategies.Provide standards input during study start-up, database lock, analysis, and submission milestones.8. Mentoring & LeadershipMentor junior team members on standards, metadata, and compliance best practices.Lead or contribute to training sessions and knowledge-sharing initiatives.Act as a reviewer/approver for complex standards, metadata, and validation deliverables.Required QualificationsEducationBachelor’s or Master’s degree in Life Sciences, Statistics, Computer Science, or a related fieldExperience8+ years of hands-on experience with SDTM and ADaMProven experience with aCRF creation/review, metadata curation, and P21E validationExperience supporting regulatory submissionsStrong understanding of the end-to-end clinical data lifecycleTechnical SkillsIn-depth knowledge of:CDISC SDTM & ADaM Implementation GuidesControlled TerminologyMetadata and traceability principlesHands-on experience with:Pinnacle 21 Enterprise (P21E)Define.xml / Define-XML 2.0Familiarity with standards and metadata toolsKnowledge of R is an added advantage, especially for validation, analytics, or automationSoft SkillsStrong analytical and problem-solving abilitiesExcellent communication and stakeholder management skillsAbility to work independently across multiple studiesHigh attention to detail and quality mindsetPreferred QualificationsExperience in a global CRO or pharmaceutical environmentExposure to multiple therapeutic areasExperience with metadata-driven standards, automation, or governance frameworksPrior role as a Standards Lead or Standards SME