Software Tester

4 weeks ago

Hyderabad Telangana India, Telangana 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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