
Clinical Systems Tester Specialist
1 day ago
Key Role: Clinical Systems Tester
We are seeking a skilled expert to support testing and validation activities within a Decentralized Clinical Trial (DCT) environment.
The successful candidate will collaborate with cross-functional teams to execute test scripts, validate workflows, and participate in system validation activities.
Key Responsibilities:
- Design and execute test scripts in Veeva EDC, aligned with protocol requirements
- Validate eCOA and IRT platform workflows
- Participate in system validation (IQ/OQ/PQ, UAT) for DCT tools including handheld and remote-use devices
- Collaborate with clinical operations, 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
Required Skills and Qualifications:
- Strong 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
Benefits include opportunities for professional growth, collaboration with experienced professionals, and contributions to innovative projects.
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