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 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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