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 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- 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 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