Software Tester

Job Profile : UAT Tester - CTMS & CDM applications

Location : Hyderabad

Notice period : immediate to 60 days

Mandatory Requirements : Clinical Systems, Safety Systems, 21 CFR part 11, GAMP 5, ICH, EMEA, MHRA regulations

Roles and Responsibilities

Must Have

• 4 to 8+ years of experience in IT testing / validation, with 2–4+ years in clinical trial systems.
• Collaborate with Clinical Operations, Data Management, Biostatistics, and IT teams to gather UAT requirements.
• Develop UAT strategy, test plans, test cases, and traceability matrices mapped to URS (User Requirements).
• Execute UAT test scripts for CTMS, EDC, eTMF, IRT / IWRS, eCOA / ePRO, and integrations with Safety and Regulatory systems.
• Validate workflows such as :
• Site / investigator setup and activation
• Subject enrollment, randomization, drug dispensing, and visit scheduling
• Data entry, query management, and monitoring
• Document upload, versioning, and eTMF compliance
• Reporting and dashboard validation
• Perform regression testing for upgrades, patches, and system integrations.
• Log defects, participate in triage, and track to closure with IT / vendors.
• Ensure compliance with ICH-GCP, GAMP 5, 21 CFR Part 11, GDPR, and other regulatory standards.
• Support end-user training, readiness checks, and sign-off for system release.
• Provide UAT summary reports and contribute to release go / no-go decisions.
• Maintain UAT documentation for audits and regulatory inspections.
• Support process improvements, automation, and efficiency in UAT cycles.

Good to Have (secondary skills)

Communication

Best Regards,

Aditi Agarwal