UAT Tester - CTMS & CDM Applications

UAT Tester - CTMS & CDM applications

Keywords Clinical Systems, Safety Systems, 21 CFR part 11, GAMP 5, ICH, EMEA, MHRA regulations

Roles and Responsibilities

Must Have

• 48+ 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,

Sanjay Kumar