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 UAT Tester for RTSM (Randomization and Trial Supply Management) Systems will be responsible for planning, designing, executing, and documenting User Acceptance Testing activities for RTSM solutions used in clinical trials. This role ensures that systems meet user requirements, function as expected, and are compliant with applicable regulatory and quality standards (e.g., GxP, 21 CFR Part 11).
Responsibilities:
- Collaborate with sponsor stakeholders and project teams to define UAT scope, scenarios, and acceptance criteria.
- Develop UAT test plans, scripts, and data based on functional requirements and study protocols.
- Execute test cases, document results, and track defects to closure in coordination with the sponsor and internal stakeholders.
- Validate randomization schemes, drug supply logic, visit schedules, and site management features specific to the RTSM system.
- Participate in UAT readiness and kick-off meetings, walkthroughs, and test script reviews.
- Ensure system behavior aligns with end-user expectations across diverse use cases including subject enrollment, kit management, unblinding, resupply triggers, and shipment tracking.
- Maintain clear and audit-ready UAT documentation, including traceability matrices, deviation logs, and summary reports.
- Support study teams during go-live readiness activities and contribute to lessons learned for future system deployments.
- Work closely with Quality, Trust and Compliance team to ensure testing adheres to applicable SOPs, validation standards, and regulatory guidelines.
Education:
- Bachelor’s degree in Life Sciences, Computer Science, Information Technology, or a related field.
Experience:
- 2–5 years of experience in User Acceptance Testing or Validation of Clinical Trial systems, ideally RTSM/IWRS/IRT platforms.
- Familiarity with clinical trial processes, ICH-GCP, and regulatory requirements (e.g., 21 CFR Part 11, EU Annex 11).
- Strong understanding of subject randomization and drug supply strategies.
- Detail-oriented with excellent documentation, troubleshooting, and communication skills.
- Proficient in defect tracking and test management tools (e.g., JIRA, SpiraTeam, Azure DevOps).
- Ability to meet deadlines and work under pressure.
- Demonstrates flexibility and adaptability to shift gears according to the priority of tasks. Possesses a high degree of flexibility, accountability, and responsibility.
- Capacity to work independently once given adequate instructions.
- Communication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results. Ability to compose clear, concise, and professional written communication.
- Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.
Skills:
- Strong collaboration and development skills.
- Proactive team player enthusiastic with high work ethics
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