06 Aug
|
Randstad
|
Hyderabad
06 Aug
Randstad
Hyderabad
Roles & Responsibilities:
- Build early to late phase studies in Medidata Rave, then program edit checks, dynamics, derivations, and custom functions in Rave Architect
- Configure study setup, including user administration, AE/SAE alerts, IRT accounts, and Coder registration
- Run UAT end-to-end from UAT Plan and site setup through test scripts, execution, and sign-off
- Track, triage, and resolve UAT issues through to go-live
- Conduct Quality Control on internal and CRO builds, covering eCRF design, edit checks, derivations, custom functions, and integrations
- Document QC findings, verify corrections, and improve QC checklists, procedures, and UAT templates
- Manage post-production changes through Rave Amendment Manager and support third-party integrations such as IxRS and labs
- You bring a quality-focused mindset and solid attention to detail in resolving system defects
This role requires:
- Bachelor's degree in mathematics, science, or a related field
- 2+ years of EDC development experience in biotech, pharmaceutical, or healthcare
- Medidata Rave experience required
- Strong understanding of UAT methodologies, test script development, and defect management
- Knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards
- Robust knowledge of Data Management and Database Development processes
- Strong cross-functional collaboration and time management in a matrix environment
- UAT coordination or execution and QC of EDC systems strongly preferred
- Medidata Builder Certification, C# programming, or TrialGrid knowledge a plus
📌 Specialist, EDC User Acceptance Testing, Quality Control & Development (Hyderabad)
🏢 Randstad
📍 Hyderabad