irt tester

ROLE : IRT TESTER
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

Job Type: Contractual / Temporary
Contract length: 12 months

Pay: ₹1,200, ₹2,000,000.00 per year

Application Question(s):

• Strong, hands-on experience with Veeva CDMS (EDC)

Work Location: Remote