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
- Valuable 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 Interested? Share

your profile
at [[email protected]]

📌 Clinical Data Standards (Hyderabad)
🏢 IQVIA India
📍 Hyderabad