Clinical Systems Associate

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., 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, and Validation/Test Summary Report o Ensure all UAT documentation is filed in the eTMF (Veeva Vault Clinical) and/or Veeva QualityDocs in accordance with applicable SOPs and TMF Index requirements o Maintain the UAT Attachments and Change Matrix and Risk Assessment as applicable o Support audit trail and/or user access review as applicable

• System Validation and Compliance

o Train on and operate in accordance with Computer System Validation (CSV) Methodology and all applicable SOPs o Assist in requirements gathering and documentation for new system implementations and change controls o Ensure systems remain in a validated state throughout the study lifecycle, including post-go-live change management o Support Computer System Validation (CSV) and Digital Systems QA (DSQA) activities as required o Participate in vendor audits and GCP Inspection Readiness activities related to systems

• Cross-Functional Collaboration and Training

o Liaise between system vendors, study teams, and CROs on issue/CAPA/Deviation management related to UAT o Develop and maintain study training materials (Study Guides, SIV slide decks) for system users o Support user access management, training assignment, and access review for systems o Provide SME Support for troubleshooting, system design review, and audit-inspection support for active and inactive studies

Do you have experience in User acceptance testing?, Do you have a Bachelor’s degree?, 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!, o Bachelor’s degree in Life Sciences, Information Technology, Clinical Research, or a related field o Minimum 3 years of experience in clinical trial operations, clinical systems, or computer system validation within the pharmaceutical or biopharmaceutical industry o Demonstrated experience coordinating or executing UAT for GxP-regulated clinical systems (IRT, eCOA, CTMS, or similar) o Working knowledge of GxP regulations applicable to clinical trial technology ystems, including 21CFR Part 11, ICH E6 (GCP), and EU GMP requirements o Familiarity with IRT system functionality (randomization, trial supply management, subject management) and/or eCOA system functionality (in-clinic and at-home patient reported outcomes) o Strong organizational skills with the ability to manage multiple concurrent UAT activities across studies and vendors o Proficiency with electronic document management systems (e.g., Veeva Vault Quality Docs, Veeva Vault Clinical eTMF) o Excellent written and verbal communication skills; ability to produce clear, audit-ready documentation

• Preferred:

o Experience with IRT and eCOA systems/platforms o Experience with DocuSign (21CFR Part 11-compliant electronic signatures) o Familiarity with CSV methodology and SDLC documentation o Experience supporting GCP inspections or vendor audits o Knowledge of TMF Reference Model and eTMF filing requirements