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 Novartis. 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- Valuable 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 [
[email protected]
]

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