Job DescriptionRole: Clinical Data Standards & Metadata Expert NMin experience: 5+ years NLocation: Hyderabad- Hybrid NABOUT THE ROLEnWeare 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. NKEY REQUIREMENTSn N Metadata Repository- Metadata-driven transformation, authoring, versioning & governance- N SDTM, ADaM, Define-XML — FDA, PMDA & EMA compliance- Must N EDC & 3rd Party DM EDC systems and third-party data management experience- Good to N Dataset validation and quality control experience- Good to have N ADaM dataset development and TFL generation experience- Positive to have NnKEY RESPONSIBILITIES: N1.



Metadata Repository & Metadata-Driven Transformation Nn Work on MDR toolssupporting metadata authoring, versioning, publishing, and governance. N Implement and manage metadata-driven transformation frameworks for SDTM/ADaM N Ensure metadata consistency, traceability, and reusability across studies. N Support MDR lifecycle activities including enhancements, UAT, and change control processes Nn2. CDISC StandardsImplementation Nn Develop and validate datasets in compliance with CDISC standards (SDTM, ADaM, Define-XML) N Ensure adherence to regulatory requirements — FDA, PMDA,and EMA N Contribute to standardization efforts including controlled terminology and metadata standards. N Collaborate with globalteams to harmonize data standards across studies NnInterested? Share your profile at []

📌 Clinical Data Standards & Metadata Specialist (Hyderabad)
🏢 IQVIA India
📍 Hyderabad