Software Tester

3 weeks ago

Hyderabad India HCLTech Full time

Job Description 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 24+ 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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