Software Tester

5 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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