IRT Test Analyst - Remote Position

Summary

Sharp Services is seeking an IRT Test Analyst to support software testing for clinical research systems. The role develops and executes test plans and use cases, tracks issues through resolution, maintains testing documentation, and supports project teams, quality investigations, audits, and regulatory compliance.

Responsibilities

• 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

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
• 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

Qualifications

Must Haves

• 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
• 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

Benefits

• Remote position