Job Description

Role: Clinical Data Standards & Metadata Expert

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Min experience: 5+ years

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Location: Hyderabad- Hybrid

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ABOUT THE ROLE

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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.

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KEY REQUIREMENTS

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- Metadata Reposi tory- Metadata-driven transformation, authoring, versioning & governance-
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- SDTM, ADaM, Define-XML — FDA, PMDA & EMA compliance- Must
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- EDC & 3rd Party DM EDC systems and third-party data management experience- Good to
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- Dataset validation and quality control experience- Good to have
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- ADaM dataset development and TFL generation experience- Positive to have
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KEY RESPONSIBILITIES:

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1.



Metadata Repository & Metadata-Driven Transformation

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- Work on MDR tools supporting metadata authoring, versioning, publishing, and governance.
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- Implement and manage metadata-driven transformation frameworks for SDTM/ADaM
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- Ensure metadata consistency, traceability, and reusability across studies.
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- Support MDR lifecycle activities including enhancements, UAT, and change control pro cesses
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2. CDISC Standards Impleme ntation

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- Develop and validate datasets in compliance with CDISC standards (SDTM, ADaM, Define-XML)
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- Ensure adherence to regulatory requirements — FDA, PMDA,and EMA
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- Contribute to standardization efforts including controlled terminology and metadata standards.
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- Collaborate with global teams to harmonize data standards across studies
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Interested? Share your profile at [ [email protected] ]

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📌 Clinical Data Standards & Metadata Specialist (Hyderabad)
🏢 IQVIA India
📍 Hyderabad