IRT Test Analyst

Essential Duties And Responsibilities

• Test project specific study configurations and protocol amendments within the IRT System and versioned releases of the IRT Core System.
• Serve as primary subject matter expert (SME) for software testing.
• Create and execute test plans and use/test cases based on requirements specifications and test plans.
• Document and track system or configuration errors through resolution.
• Create testing summaries at the end of test execution and work with IRT Project Manager on resolution plans.
• Communicate testing status to the project team.
• Maintain testing documentation.
• Review and provide input on requirement specifications, focusing on risk to patient safety and data integrity.
• Peer review test cases and testing documentation.
• Aid in the development of testing timelines and client acceptance testing setup.
• Ensure timely delivery of all project-related deliverables and escalate risks to timelines to the IRT Project Manager.
• Maintain the IRT Project File.
• Adhere to Standard Operating Procedures (SOP) and Work Instructions (WI).
• Contribute SME knowledge as applicable to create/update SOPs.
• Participate in internal/external audits and regulatory investigations.
• Participate in Quality Investigations.
• Initiate Quality Events as defined in Standard Operating Procedures.

Qualifications

• Bachelor’s degree or equivalent work experience.
• 2-3 years’ experience in a similar quality management or testing role.
• 3+ years’ experience working at a CRO or pharmaceutical company on clinical research and development projects with experience using IRT, EDC, or ePRO Systems.
• Knowledge of clinical research industry, standard practices, and GHC, ICH/GCP guidelines, and FDA Regulations.
• Understanding of regulations associated with clinical trial data handling, including HIPAA, GDPR, and 21 CFR Part 11.