Offshore Remote Clinical Systems Validation Specialist
1 day ago
Job Title: Clinical Systems Tester
Description:
We are seeking a highly skilled Clinical Systems Tester with expertise in Veeva CDMS (Electronic Data Capture) and experience with eCOA and IRT platforms. This role involves testing and validation activities within a Decentralized Clinical Trial (DCT) environment, requiring flexibility across various digital systems and patient-facing technologies.
Key Responsibilities:
- Develop and execute test scripts in Veeva EDC, aligned with protocol requirements
- Validate workflows across eCOA and IRT platforms to ensure seamless integration and data accuracy
- 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
Requirements:
- Strong experience with Veeva CDMS (EDC)
- Working knowledge of eCOA platforms (e.g., Medidata, YPrime, Clinical Ink)
- IRT system experience (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)
- Attention to detail with strong documentation and communication skills
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