Software Tester

7 days ago

Hyderabad, India HCLTech Full time
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)
Hands-on experience with Clinical applications (e.g., Medidata Rave, Oracle InForm, Veeva CTMS, Medrio, Oracle Siebel CTMS, Veeva eTMF, IRT/IWRS systems).
Knowledge of clinical trial processes (site initiation, subject enrollment, monitoring, data management, trial closure).
Familiarity with UAT methodology, SDLC, and CSV (Computer System Validation) practices.
Strong knowledge of ICH-GCP, FDA, EMA, and MHRA clinical trial regulations.
Proficiency in defect tracking tools (e.g., JIRA, HP ALM, Veeva QMS).
Excellent communication, analytical, and problem-solving skills.
Ability to work cross-functionally with Clinical, QA, Data, and IT teams.
Communication
Immaculate communication and handles multiple clients/ projects
Works in Consulting capacity
Best Regards,
Aditi Agarwal

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