
Remote IRT Tester
3 days ago
We are seeking a skilled Clinical Systems Tester to support testing and validation activities within a Decentralized Clinical Trial (DCT) environment.
The ideal candidate will possess core expertise in Veeva CDMS (Electronic Data Capture) and strong hands-on experience with eCOA and IRT platforms.
Key responsibilities include:
- Developing and executing test scripts in Veeva EDC, aligned with protocol requirements
- Validating workflows across eCOA and IRT platforms
- Participating in system validation (IQ/OQ/PQ, UAT) for DCT tools, including handheld and remote-use devices
- Collaborating with clinical operations, data management, and vendors to troubleshoot issues and verify system behavior
- Reviewing data capture logic and supporting query testing to ensure data accuracy
- Documenting test execution results, managing traceability, and supporting audit-readiness
- Contributing to ongoing improvements in test processes across DCT systems
Required qualifications include:
- Strong, hands-on experience with Veeva CDMS (EDC)
- Working knowledge of eCOA platforms (e.g., Medidata, YPrime, Clinical Ink)
- Experience with IRT systems (e.g., Almac, 4G, Bioclinica)
- Prior involvement in DCT environments, including testing for remote or device-based workflows
- Understanding of clinical trial regulatory requirements (21 CFR Part 11, GxP)
- Detail-oriented with strong documentation and communication skills
This is an exciting opportunity to work on innovative solutions and contribute to the success of our organization.
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