
Offshore, Long-term Contract
3 weeks ago
Role: IRT TESTER (offshore)Location: India (Remote)Duration: Long Term Contract Job Description:OVERVIEW We are looking for a well-rounded Clinical Systems Tester with core expertise in Veeva CDMS (EDC) and strong hands-on experience with e COA 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 e COA (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 e COA platforms (e.g., Medidata, YPrime, Clinical Ink)
• Experience with IRT systems (e.g., Almac, 4 G, Bioclinica)
• Prior involvement in DCT environments, including testing for remote or device-based workflows
• Understanding of clinical trial regulatory requirements (21 CFR Part 11, Gx P)
• Detail-oriented with strong documentation and communication skills The Company is an equal opportunity employer and makes employment decisions on the basis of merit and business needs.
The Company will consider all qualified applicants for employment without regard to race, color, religious creed, citizenship, national origin, ancestry, age, sex, sexual orientation, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law.
To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, the Company will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result.Thanks & RegardsPradeep PathakSenior Technical RecruiterKPG99 Inc.
|Direct: 609-325-2290Email id: pradeepk@kpgtech.com / pradeep1@kpg.in : Address: 3240 E State St EXT , Hamilton, NJ 08619
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