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Remote Clinical Trials Quality Assurance Specialist
2 weeks ago
We are seeking a highly skilled Clinical Systems Tester to join our team. This is a key role in ensuring the quality and accuracy of clinical trial data by testing and validating digital systems and patient-facing technologies.
Responsibilities:
- Develop 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
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