Clinical Systems Associate

### **Opportunity Details** On Assignment **Clinical Systems Associate** Remote, USA KPS Life is hiring a Clinical Systems Associate dedicated remotely to one of our sponsor partners to support UAT and clinical systems activities across global clinical trials. This role partners closely with Clinical Operations, QA, vendors, and study teams to ensure systems like IRT and eCOA are validated, compliant, and ready for go\-live. Ideal candidates will have experience with GxP\-regulated clinical systems, UAT coordination, and clinical trial operations within pharma or biotech. If you have this experience, please reach out to KPS Life today! Position Summary: The Clinical Systems Associate serves as a key contributor within the Development Operations department – Clinical Systems and TMF Operations group – responsible for supporting clinical systems activities including coordinating, executing, and documenting User Acceptance Testing activities for clinical systems used in the conduct of clinical trials. This role ensures that IRT, eCOA, and other systems are validated and fit\-for\-purpose prior to go\-live, safeguarding patient safety and data integrity in accordance with GxP Regulatory requirements and sponsors processes and SOPs. The Clinical Systems Coordinator serves as the primary point of contact for UAT planning, tester coordination, issue management, and documentation across multiple concurrent studies, working in close collaboration with Clinical Trial Operations, Clinical Quality Assurance, Data Management, Biostatistics, TechOps/Clinical Supplies \& Logistics, and system vendors. Responsibilities: * User Acceptance Testing (UAT) Planning \& Coordination o Author, review, and manage approval of study\-specific UAT plans o Coordinate UAT tester pre\-execution training, assignments, site/role assignments, and testing schedules across all IRT/eCOA systems/studies o Serve as the primary liaison between study teams and IRT/eCOA vendors during UAT Planning and execution o Ensure UAT activities are aligned with the applicable User Requirements Specification (URS), System Requirements Document (SRD), and IT GxP Change Control Requirements * UAT Execution and Issue Management o Coordinate and oversee execution of UAT test scripts by designated testers o Manage the UAT Issues Log throughout the testing period, tracking issue categorization (Low/Moderate/High), resolution status, and go\-live readiness o Coordinate time\-travel, testing settings, and dependency/pre\-requisite configuration in UAT environments as required for test script execution o Escalate unresolved issues to the appropriate functional leads (E.g., clinical QA, IRT Manager, vendor project team) and ensure timely resolution prior to system go\-live * UAT Documentation and Deliverables o Generate and manage approval of all UAT Deliverables, including: UAT Plan, UAT Test Scripts, UAT Summary Report, UAT Approval Form, a