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Clinical Systems Specialist
2 weeks ago
Job Title:
Clinical Systems Specialist – Veeva CDMS and eCOA/IRT Expertise
Job Summary:
We are seeking a highly skilled Clinical Systems Tester to join our team. As a key member of our clinical operations department, you will be responsible for authoring and executing test scripts in Veeva EDC, validating workflows across eCOA and IRT platforms, and collaborating with cross-functional teams to ensure system behavior meets requirements.
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 (IQ/OQ/PQ, UAT) 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 (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.
