QA Analyst, Clinical Systems

The Clinical Systems QA Analyst will perform quality reviews of the User Requirements Specification and Study Protocol, create Test Scripts, and execute any other User Acceptance Testing deliverables and Validation projects.

Responsibilities:

• Provide test scoping within required timelines based on an analysis of study and system design
• Identify study customizations required and if any, conduct impact assessment.
• Perform quality reviews of the User Requirements Specification and Study Protocol to determine functional design.
• Engage business teams to determine business requirements and conduct gap analysis to ensure requirements are fit for purpose
• Create UAT Plan, test scenarios and test cases adhering to business and system specifications.
• Complete all project deliverables, following the test process and methodologies as defined within the company SOPs.
• Train sponsor / CRO testers, and vendor staff as applicable in UAT execution.
• Provide excellent test execution support and resolution management to close-out -- including logging, tracking, and driving UAT finding and root cause analysis, and any CAPAs required.

Required Experience and Qualifications:

• Extensive knowledge of Interactive Response Technology (IRT) / Randomization and Trial Supply Management (RTSM) 3+ year’s experience with IRT / RTSM services delivery and systems implementation.
• 3+ years’ experience in a similar role / environment
• Experience working in a regulated environment.
• Experience with Software implementation and testing experience in clinical research or a supply chain related industry.
• Project management experience working with cross-functional business and technical teams.
• Familiarity of cGxP principles, and computer software validation (CSV).
• Experience with GAMP principles and application of preferred