Clinical Data Standards & Metadata Specialist

IQVIA India; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

IQVIA India is seeking an experienced Clinical Data Standards & Metadata Expert to support global clinical development programs. The role focuses on metadata repositories, metadata-driven transformations, and CDISC standards implementation for SDTM/ADaM.

The ideal candidate will have 5+ years of hands-on experience with MDR tools, metadata governance, and regulatory compliance across FDA, PMDA, and EMA requirements.

Qualifications

• SDTM, ADaM, Define-XML knowledge for regulatory compliance.
• Experience with EDC systems and third-party data management.
• Experience with dataset validation and quality control.
• ADaM development and TFL generation experience.

Responsibilities

• Work on MDR tools for metadata authoring, versioning, publishing and governance.
• Implement and manage metadata-driven transformation for SDTM/ADaM.
• Ensure metadata consistency, traceability, and reusability across studies.
• Support MDR lifecycle activities including enhancements, UAT, and change control processes.

Skills

SDTM/ADaM/Define-XML

EDC & third-party DM EDC

Dataset validation

ADaM development & TFL

Tools

MDR tools

Job description

Role: Clinical Data Standards & Metadata Expert

Min experience: 5+ years

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

• 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 life cycle 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