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 Repository- 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 processes
2. CDISC Standards Implementation
- 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
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