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Metro mid-level QA title increases competition, but clinical RTSM specialization reduces applicant pool.
Strong clinical RTSM and regulatory requirements limit transferability to other industries.
Explicit years, mandatory RTSM/IRT domain experience, and regulatory compliance requirements enforce strict shortlisting.
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Plan, design, execute, and document User Acceptance Testing (UAT) for RTSM (Randomization and Trial Supply Management) systems used in clinical trials.
Validate system functions such as randomization schemes, drug supply logic, visit schedules, and site management to ensure alignment with end-user requirements and regulatory standards (e.g., GxP, 21 CFR Part 11).
Maintain audit-ready UAT documentation and support study teams during go-live readiness and post-release lessons learned activities.
2–5 years of experience in User Acceptance Testing or Validation of Clinical Trial systems, ideally RTSM/IWRS/IRT platforms.
Bachelor’s degree in Life Sciences, Computer Science, Information Technology, or related field.
Familiarity with clinical trial processes and regulatory requirements such as ICH-GCP, 21 CFR Part 11, and EU Annex 11.
Location: Role based at Bangalore office.
Strong understanding of clinical trial subject randomization and drug supply strategies relevant to RTSM systems.
Detail-oriented with proven ability to maintain clear, audit-ready documentation and proficiency in defect tracking/test management tools (JIRA, SpiraTeam, Azure DevOps).
Able to collaborate effectively with sponsor stakeholders and internal teams to define UAT scope and acceptance criteria while working independently once given instructions.