Senior Clinical Systems Tester

3 days ago


Mysore, Karnataka, India beBeeClinical Full time ₹ 9,00,000 - ₹ 12,00,000
Job Description

We are seeking a seasoned Clinical Systems Tester to join our team. This is a unique opportunity to leverage your expertise in Veeva CDMS (Electronic Data Capture) and eCOA platforms to drive high-quality testing and validation activities within a Decentralized Clinical Trial environment.

This role requires flexibility, adaptability, and a strong ability to collaborate with cross-functional teams to troubleshoot issues and ensure system behavior aligns with protocol requirements.


Key Responsibilities
  • Test Script Development: Author and execute test scripts in Veeva EDC, aligned with protocol requirements.
  • Workflow Validation: Validate workflows across eCOA and IRT platforms to ensure seamless data capture and transfer.
  • System Validation: Participate in system validation (IQ/OQ/PQ, UAT) for DCT tools, including handheld and remote-use devices.
  • Collaboration and Troubleshooting: Collaborate with clinical ops, data management, and vendors to troubleshoot issues and verify system behavior.
  • Data Accuracy: Review data capture logic and support query testing to ensure data accuracy.
  • Documentation and Traceability: Document test execution results, manage traceability, and support audit-readiness.
  • Process Improvement: Contribute to ongoing improvements in test processes across DCT systems.
Requirements

To be successful in this role, you will need:

  • Veeva CDMS (EDC) Experience: Strong, hands-on experience with Veeva CDMS (EDC).
  • eCOA Platforms: Working knowledge of eCOA platforms, such as Medidata, YPrime, or Clinical Ink.
  • IRT Systems: Experience with IRT systems, like Almac, 4G, or Bioclinica.
  • DCT Environments: Prior involvement in DCT environments, including testing for remote or device-based workflows.
  • Clinical Trial Regulatory Requirements: Understanding of clinical trial regulatory requirements, including 21 CFR Part 11 and GxP.
  • Documentation and Communication Skills: Detail-oriented with strong documentation and communication skills.


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