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Clinical Systems Specialist

2 weeks ago

Malappuram, Kerala, India beBeeTester Full time ₹ 10,00,000 - ₹ 15,00,000

Clinical Systems Tester

Job Description:

We are looking for a well-rounded Clinical Systems Tester with core expertise in Veeva CDMS (EDC) and strong hands-on experience with eCOA and IRT platforms. This role supports testing and validation activities within a Decentralized Clinical Trial (DCT) environment, requiring flexibility across various digital systems and patient-facing technologies.

Key Responsibilities:
  • Author and execute test scripts in Veeva EDC, aligned with protocol requirements
  • Validate workflows across eCOA (electronic Clinical Outcome Assessments) and IRT (Interactive Response Technology) 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.
Required Skills and Qualifications:
  • 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.