
Remote - IRT Testers- Offshore
3 days ago
Position :IRT Testers
Location: Remote
Duration : Contract
Must have IRT platform experience.
INDUSTRY LIFE SCIENCES
LOCATION REMOTE (India) reporting to Cambridge, MA 02139
INTERVIEW pre-qualifying SPARK HIRE ASSESSMENT and MS TEAMS conversation
OVERVIEW
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
• 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.
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