The IRT Test Analyst will use software test methodologies to write and execute test plans and use cases related to the functionality of the IRT System and project specific configuration and custom coding. The Test Analyst will be responsible to document and track system or configuration errors through resolution.

Essential Duties and Responsibilities

The IRT Test Analyst is responsible for the testing of project specific study configurations and protocol amendments within the IRT System and versioned releases of the IRT Core System. The IRT Test Analyst will be expected to serve as primary subject matter expert (SME) for software testing.

• Write Test Plans in accordance with GAMP 5 and software methodologies.
• Create use and/or test cases based off the requirements specifications and test plan.
• Execute approved test cases.
• Maintain issues log of errors noted during test execution.
• Create testing summary at the end of test execution, and work with IRT Project Manager on resolution plan.  
• Communicate status of testing to the project team.
• Maintain Testing Documentation.
• Review and provide input in requirement specifications, high focus on risk to patient safety and data integrity.
• Provide test case and testing documentation peer reviews.
• Assist IRT Project Manager with the development of testing timelines.
• Assist IRT Project Manager with the set-up of Client Acceptance Testing.
• Ensure timely delivery of all project related deliverables, escalate any risk to the timelines to the IRT Project Manager.
• Assist in the maintenance of the IRT Project File.
• Understand and adhere to Standard Operating Procedures (SOP) and Work Instructions (WI)
• Contribute SME knowledge as applicable to create/update Standard Operating Procedures (SOP)
• Prepare for and participate in internal/external audits and regulatory investigations.
• Participate in Quality Investigations.
• Initiate Quality Events as defined in Standard Operating Procedures.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Required Skills:

• Experience with and demonstrated understanding of computer systems and software application implementation including knowledge of software development life cycle.
• Strong communication skills, job requires communication with internal stakeholders and vendors.
• Basic knowledge of SQL, XML Web services, sFTP and SAS.
• Working knowledge of personal computers and Microsoft Office Products, including Word, Project, Excel and Power Point.

Required Experience:

• Bachelor’s degree or equivalent work experience.
• 2-3 years’ experience in a similar quality management or testing role.
• Must have 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.
• Knowledge and understanding of regulations associated with clinical trial data handling, including HIPAA, GDPR and 21 CFR Part 11.