
Clinical Systems Validation Specialist
5 days ago
We are seeking a skilled Clinical Systems Tester to support testing and validation activities within a DCT environment.
This role requires flexibility across various digital systems and patient-facing technologies, with a focus on Veeva CDMS (EDC), eCOA, and IRT platforms.
Key Responsibilities:
- Author and execute test scripts in Veeva EDC, aligned with protocol requirements
- Validate workflows across eCOA and IRT platforms
- Participate in system validation for DCT tools, including handheld and remote-use devices
- Collaborate with clinical ops, data management, and vendors to troubleshoot issues and verify system behavior
- Review data capture logic and support query testing to ensure data accuracy
- Document test execution results, manage traceability, and support audit-readiness
- Contribute to ongoing improvements in test processes across DCT systems
Requirements:
- Strong, hands-on experience with Veeva CDMS (EDC)
- Working knowledge of eCOA platforms, such as Medidata, YPrime, or Clinical Ink
- Experience with IRT systems, such as Almac, 4G, or Bioclinica
- Prior involvement in DCT environments, including testing for remote or device-based workflows
- Understanding of clinical trial regulatory requirements, including 21 CFR Part 11 and GxP
- Detail-oriented with strong documentation and communication skills
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