Clinical Systems UAT Analyst

Summary

Poxy Clinical helps clinical trial sponsors test and validate the systems supporting their studies, with a focus on user acceptance testing and clinical trial technology. The Clinical Systems UAT Analyst will lead and support UAT for clinical trial technologies, developing test materials, guiding stakeholders, identifying risks, and supporting compliant system implementations and issue resolution.

Responsibilities

• Develop UAT scope for IRT/RTSM, eCOA, and clinical system integrations by analyzing study requirements, protocols, system design, workflows, and data flows
• Review user requirements specifications, study protocols, functional specifications, and related materials for clarity, completeness, consistency, and testability
• Identify study-specific requirements and system customizations; assess their potential impact on testing scope, timelines, and deliverables
• Develop UAT plans, test scripts, test scenarios, and other deliverables. Ensure testing is complete, traceable to requirements, and focused on meaningful study workflows, critical risks, edge cases, and integration points
• Apply risk-based testing principles and industry best practices, using critical thinking to determine what needs to be tested and to what depth
• Map business and functional requirements to processes, scenarios, and test coverage, including relevant training and support procedures
• Complete UAT deliverables in accordance with Poxy Clinical’s defined processes and timelines
• Train sponsor testers and vendor staff, when applicable, on UAT processes and execution
• Lead UAT execution support and issue resolution through closeout, including logging and tracking findings, coordinating root-cause analysis, and following up on corrective and preventive actions (CAPAs), as applicable
• Perform test execution on a sponsor’s behalf when needed
• Develop sponsor-specific UAT standards when needed and capture lessons learned
• Support validation and quality activities for quality management systems and other clinical trial technologies, including clinical supply systems
• Follow company SOPs, industry best practices, and applicable Good Clinical Practice (GCP) and Good Documentation Practice (GDP) standards
• Support business development activities, including responses to RFPs and RFIs
• Complete vendor qualification activities, including vendor questionnaires, and participate in vendor audits
• Support business operations related to the UAT process, service value proposition, and KPI and metrics management

Skills

• • Able to recognize project risks and challenges and escalate appropriately
• • Applies project management methods to keep teams and stakeholders aligned and support on-time UAT delivery
• • Works effectively in a client-facing role with cross-functional study teams and IRT stakeholders
• • Follows Poxy Clinical's governance processes, procedures, and applicable compliance standards and guidance
• • Understands system implementation methods, including requirements gathering, design, build, testing, and deployment, and how Agile and Waterfall approaches apply to validation activities
• • Prioritizes effectively, adapts quickly to changing conditions, and manages multiple UATs and competing deadlines while maintaining attention to detail
• • Demonstrates knowledge of RTSM/IRT and experience with UAT for RTSM/IRT, eCOA, and clinical system integrations
• • Takes ownership of projects and delivers accurate, high-quality work
• • Communicates clearly in writing and verbally, presents effectively, and explains company services and technology to internal and external stakeholders
• • Uses critical thinking, sound judgment, and problem-solving skills to assess risks, investigate issues, and determine appropriate next steps
• • Asks thoughtful questions, listens carefully, and engages sponsors, testers, and vendors constructively to clarify requirements and resolve uncertainties
• • Takes initiative, adapts to direction and changing priorities, and collaborates effectively with others
• • Demonstrates strong organization, attention to detail, and the ability to guide and support others without direct authority
• • Bachelor's degree in a technical discipline, such as mathematics, science, engineering, or computing, is required
• • 3+ years of industry experience, including at least two years in a quality role within a regulated environment
• • At least 2 years of experience in a testing or validation role on client-facing software implementation projects in regulated environments, with hands-on involvement in UAT for RTSM/IRT, eCOA, and clinical system integrations, as well as system validation and issue resolution in clinical research, life sciences, or clinical supply and supply chain industries
• • Project management experience working with cross-functional business and technical teams
• • In-depth knowledge of cGxP principles, GAMP guidance, and computer system validation (CSV), including risk-based approaches
• Proficient in Microsoft Office Suite and related software programs
• Applicants must be legally authorized to work in the United States at the time of hire
• Poxy Clinical does not provide employment visa sponsorship for this position
• An advanced degree or equivalent relevant experience is preferred
• Experience in an FDA-regulated environment is highly preferred

Qualifications

Must Haves

• • Able to recognize project risks and challenges and escalate appropriately
• • Applies project management methods to keep teams and stakeholders aligned and support on-time UAT delivery
• • Works effectively in a client-facing role with cross-functional study teams and IRT stakeholders
• • Follows Poxy Clinical's governance processes, procedures, and applicable compliance standards and guidance
• • Understands system implementation methods, including requirements gathering, design, build, testing, and deployment, and how Agile and Waterfall approaches apply to validation activities
• • Prioritizes effectively, adapts quickly to changing conditions, and manages multiple UATs and competing deadlines while maintaining attention to detail
• • Demonstrates knowledge of RTSM/IRT and experience with UAT for RTSM/IRT, eCOA, and clinical system integrations
• • Takes ownership of projects and delivers accurate, high-quality work
• • Communicates clearly in writing and verbally, presents effectively, and explains company services and technology to internal and external stakeholders
• • Uses critical thinking, sound judgment, and problem-solving skills to assess risks, investigate issues, and determine appropriate next steps
• • Asks thoughtful questions, listens carefully, and engages sponsors, testers, and vendors constructively to clarify requirements and resolve uncertainties
• • Takes initiative, adapts to direction and changing priorities, and collaborates effectively with others
• • Demonstrates strong organization, attention to detail, and the ability to guide and support others without direct authority
• • Bachelor's degree in a technical discipline, such as mathematics, science, engineering, or computing, is required
• • 3+ years of industry experience, including at least two years in a quality role within a regulated environment
• • At least 2 years of experience in a testing or validation role on client-facing software implementation projects in regulated environments, with hands-on involvement in UAT for RTSM/IRT, eCOA, and clinical system integrations, as well as system validation and issue resolution in clinical research, life sciences, or clinical supply and supply chain industries
• • Project management experience working with cross-functional business and technical teams
• • In-depth knowledge of cGxP principles, GAMP guidance, and computer system validation (CSV), including risk-based approaches
• Proficient in Microsoft Office Suite and related software programs
• Applicants must be legally authorized to work in the United States at the time of hire
• Poxy Clinical does not provide employment visa sponsorship for this position

Nice to Haves

• An advanced degree or equivalent relevant experience is preferred
• Experience in an FDA-regulated environment is highly preferred

Benefits

• Blue Cross Blue Shield Health & Dental insurance, with company contribution
• Vision Insurance
• HSA account, with company contribution
• 401k with a 4% company match
• A generous paid time off program that includes (2 weeks’ PTO to start, 10 paid holidays and a company paid shut down week in December).
• Assistance paying off student loans through our Educational Assistance Program.
• Flexible, remote work schedule.