Clinical Data Standards & Metadata Specialist
IQVIA India
Clinical Data Standards & Metadata Specialist
Start Date
Starts Immediately
CTC (ANNUAL)
Competitive salary Competitive salary
Experience
5 year(s)
5 year(s)
Apply By
Not Provided
Posted 2 weeks ago
Job
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About the job
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 Reposi tory- 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 pro cesses
2. CDISC Standards Impleme ntation
- 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 [ View email address on internshala.com ]
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Who can apply
Only those candidates can apply who:
1. have minimum 5 years of experience
Salary
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Duration:
Salary during probation:
After probation:
Annual CTC: Competitive salary
Number of openings
1
Editor’s note
Information above is Internshala's interpretation and paraphrasing of what we found on the shared link.
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