Clinical Data Standards & Metadata Specialist

Role: Clinical Data Standards & Metadata Expert Min experience: 5 years Location: Hyderabad- Hybrid ABOUT THE ROLE We 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. KEY REQUIREMENTS Metadata Reposi tory- Metadata-driven transformation, authoring, versioning & governance- SDTM, ADaM, Define-XML — FDA, PMDA & EMA compliance- Must EDC & 3rd Party DM EDC systems and third-party data management experience- Good to Dataset validation and quality control experience- Good to have ADaM dataset development and TFL generation experience- Good to have KEY RESPONSIBILITIES: 1. Metadata Repository & Metadata-Driven Transformation Work on MDR tools supporting metadata authoring, versioning, publishing, and governance. Implement and manage metadata-driven transformation frameworks for SDTM/ADaM Ensure metadata consistency, traceability, and reusability across studies. Support MDR lifecycle activities including enhancements, UAT, and change control pro cesses 2. CDISC Standards Impleme ntation Develop and validate datasets in compliance with CDISC standards (SDTM, ADaM, Define-XML) Ensure adherence to regulatory requirements — FDA, PMDA,and EMA Contribute to standardization efforts including controlled terminology and metadata standards. Collaborate with global teams to harmonize data standards across studies Interested? Share your profile at ( )