- 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
- 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
- Work with EDC platforms (e.g., Medidata Rave) for clinical data acquisition
- Handle third-party/vendor data integration and mapping to CDISC standards
- Support creation and maintenance of Data Transfer Specifications (DTS) and external data flows
- Perform validation and QC activities including double programming and dataset review
- Support validation documentation (test scripts, traceability matrices, UAT execution)
- Ensure compliance with GxP and regulatory validation standards (21 CFR Part 11)
- Create and validate ADaM datasets as per Statistical Analysis Plan (SAP)
- Develop Tables, Listings, and Figures (TFLs) for clinical study reports
- Support statistical analysis and regulatory submissions
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
