We are seeking an experienced Principal Data Standards Analyst to provide leadership in clinical data standards, metadata management, and governance. The role will support the implementation and maintenance of industry-standard clinical metadata, ensuring consistency and compliance across clinical studies.
The ideal candidate will have solid expertise in CDISC standards (CDASH, SDTM, Controlled Terminology, and External Data) and a thorough understanding of end-to-end clinical data processes
- Key Responsibilities
- Serve as a subject matter expert for clinical data standards, metadata governance, and CDISC compliance
- . Lead the review and implementation of study-specific metadata, ensuring alignment with organizational standards and regulatory requirements
- . Review and oversee study requests related to data collection, external data, controlled terminology, and SDTM standards
- . Collaborate with cross-functional teams to develop and maintain metadata specifications and standards
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Facilitate metadata review meetings and provide guidance on best practices for clinical data standards
- . Support the development, maintenance, and governance of global and therapeutic area-specific standards
- . Monitor regulatory and industry standards updates and drive their adoption across studies
- . Contribute to process improvements and standardization initiatives within clinical data management
- . Provide mentorship and guidance to study teams on metadata and data standards implementation
- Required Experience
- 7+ years of experience in the pharmaceutical, biotechnology, or CRO industry with a focus on Clinical Data Standards, Metadata Management, or Clinical Data Management
- . Strong knowledge of CDISC standards, including CDASH, SDTM, Controlled Terminology, and External Data models
- . Experience with metadata governance, standards implementation, and clinical data lifecycle management
- . Understanding of regulatory requirements related to clinical data standards
- .CDISC certification is a plus
📌 Senior Data Standards and Metadata Specialist (Hyderabad)
🏢 Iqvia
📍 Hyderabad
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