The Manager of UAT Services leads the planning, coordination, and execution of User Acceptance Testing across enterprise systems, ensuring compliance and high quality in clinical trials.
About Us:
Endpoint is an interactive response technology (IRT®) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help sponsors and pharmaceutical companies achieve clinical trial success. Our solutions, realized through the proprietary PULSE® platform, have proven to maximize the supply chain, minimize operational costs, and ensure timely and accurate patient dosing. Endpoint is headquartered in Raleigh-Durham, North Carolina with offices across the United States, Europe, and Asia.
Position Overview:
The Manager, UAT Services leads the strategic planning, coordination, and execution of User Acceptance Testing (UAT) across enterprise systems, including platforms used in clinical trials such as RTSM, EDC, eCOA, and CTMS. This role ensures high-quality, compliant, and business-aligned system implementations by managing UAT resources, processes, and deliverables from planning through deployment.
Responsibilities:
- Lead and manage the UAT Services team responsible for the planning, development, execution, and documentation of UAT across multiple systems.
- Collaborate with business stakeholders, system owners, project managers, and QTC to define UAT strategy, scope, and success criteria.
- Develop and maintain standard operating procedures (SOPs), templates, and best practices related to UAT planning and execution in a regulated environment.
- Oversee the creation and review of UAT deliverables including test plans, test scripts, traceability matrices, test data, and summary reports.
- Manage the UAT test execution lifecycle, including defect tracking, resolution coordination, retesting, and final sign-off.
- Ensure UAT activities are aligned with applicable regulatory and compliance standards such as 21 CFR Part 11, GAMP 5, GxP, and ICH-GCP.
- Monitor and report UAT progress, risks, and quality metrics to project teams and senior leadership.
- Provide leadership, mentorship, and performance management for UAT staff, including testers and business analysts.
- Serve as the point of escalation for UAT-related issues and decision-making.
- Continuously assess and improve UAT processes, toolsets, and team capabilities.
- Support audits and inspections by ensuring audit-ready documentation and compliance with internal and external quality requirements.
Education:
- Bachelor’s degree in Life Sciences, Computer Science, Information Technology, or a related field.
Experience:
- 6+ years of experience in software/system testing in regulated industries, with at least 2–3 years in a leadership or management role.
- Proven expertise in UAT planning and execution for enterprise clinical systems, including RTSM, EDC, and CTMS.
- Deep understanding of regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11), SDLC, and computer system validation (CSV) principles.
- Strong leadership, communication, and stakeholder management skills.
- Proficient in test management and defect tracking tools such as JIRA, SpiraTeam, Azure DevOps or similar.
- Ability to manage multiple priorities and lead cross-functional teams in a fast-paced, dynamic environment
Skills:
- Strong collaboration and development skills.
- Proactive team player enthusiastic with high work ethics
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Top Skills
Azure Devops
Ctms
Ecoa
Edc
JIRA
Rtsm
Spirateam
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