Remote - IRT Testers- Offshore

3 weeks ago

India KPG99 INC Full time

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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