Job Description
**Key Responsibilities**
**1. Metadata Repository & Metadata-Driven Transformation (Must Have)**
+ Work on **Metadata Repository (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 processes
**2. 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 standards
+ Collaborate with global teams to harmonize data standards across studies
**3. EDC & Third-Party Data Management (Good to Have)**
+ Work with EDC platfo...
**1. Metadata Repository & Metadata-Driven Transformation (Must Have)**
+ Work on **Metadata Repository (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 processes
**2. 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 standards
+ Collaborate with global teams to harmonize data standards across studies
**3. EDC & Third-Party Data Management (Good to Have)**
+ Work with EDC platfo...