Quality Analyst

QA

we need off-shore (India) candidates.

all candidates will be required to complete a SparkHire Assessment.

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 Experience:

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