Key Responsibilities
1. Metadata Repository & Metadata-Driven Transformation (Must Have)
Work on Metadata Repository (MDR) tools supporting metadata authoring, versioning, publishing, and governanceImplement and manage metadata-driven transformation frameworks for SDTM/ADaMEnsure metadata consistency, traceability, and reusability across studiesSupport MDR lifecycle activities including enhancements, UAT, and change control processes2. CDISC Standards Implementation (Must Have)
Develop and validate datasets in compliance with CDISC standards (SDTM, ADaM, Define-XML)Ensure adherence to regulatory requirements (FDA, PMDA, EMA)Contribute to standardization efforts including controlled terminology and metadata standardsCollaborate with global teams to harmonize data standards across studies3. EDC & Third-Pa...