Job Description
Role: Clinical Data Standards & Metadata Expert
n Min experience: 5+ years
n Location: Hyderabad- Hybrid
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n ABOUT THE ROLE
nWe are looking for an experienced Clinical Data Standards & Metadata Specialist with a minimum of 5 years of experience to join our team supporting our FSP client. The ideal candidate will bring deep expertise in Metadata Repository tools, metadata-driven transformation frameworks, and CDISC standards implementation to support global clinical development programs.
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n KEY REQUIREMENTS
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- Metadata Reposi tory- Metadata-driven transformation, authoring, versioning & governance-n
- SDTM, ADaM, Define-XML — FDA, PMDA & EMA compliance- Mustn
- EDC & 3rd Party DM EDC systems and third-party data management experience- Good ton
- Dataset validation and quality control experience- Good to haven
- ADaM dataset development and TFL generation experience- Valuable to haven

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n KEY RESPONSIBILITIES:
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Metadata Repository & Metadata-Driven Transformation
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- Work on MDR tools supporting metadata authoring, versioning, publishing, and governance.n
- Implement and manage metadata-driven transformation frameworks for SDTM/ADaMn
- Ensure metadata consistency, traceability, and reusability across studies.n
- Support MDR lifecycle activities including enhancements, UAT, and change control pro cesses n

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n2. CDISC Standards Impleme ntation
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- Develop and validate datasets in compliance with CDISC standards (SDTM, ADaM, Define-XML)n
- Ensure adherence to regulatory requirements — FDA, PMDA,and EMAn
- Contribute to standardization efforts including controlled terminology and metadata standards.n
- Collaborate with global teams to harmonize data standards across studiesn

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nInterested? Share your profile at [ [email protected] ]
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📌 Clinical Data Standards (Hyderabad)
🏢 IQVIA India
📍 Hyderabad