Clinical Systems Associate
kps life · United States
- Hybrid
- Full-time
- $95,000 / year
- United States
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Job highlights
- Support global clinical trials with UAT and systems.
- Ensure IRT and eCOA systems are validated and compliant.
- Collaborate with cross-functional teams and vendors.
- Manage UAT planning, execution, and documentation.
- Requires 3+ years clinical systems or CSV experience.
About the role
Clinical Systems Associate - Remote
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
- Author, review, and manage approval of study-specific UAT plans
- Coordinate UAT tester pre-execution training, assignments, site/role assignments, and testing schedules across all IRT/eCOA systems/studies
- Serve as the primary liaison between study teams and IRT/eCOA vendors during UAT Planning and execution
- 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
- Coordinate and oversee execution of UAT test scripts by designated testers
- Manage the UAT Issues Log throughout the testing period, tracking issue categorization (Low/Moderate/High), resolution status, and go-live readiness
- Coordinate time-travel, testing settings, and dependency/pre-requisite configuration in UAT environments as required for test script execution
- 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
- 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
- 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
- Maintain the UAT Attachments and Change Matrix and Risk Assessment as applicable
- Support audit trail and/or user access review as applicable
System Validation and Compliance
- Train on and operate in accordance with Computer System Validation (CSV) Methodology and all applicable SOPs
- Assist in requirements gathering and documentation for new system implementations and change controls
- Ensure systems remain in a validated state throughout the study lifecycle, including post-go-live change management
- Support Computer System Validation (CSV) and Digital Systems QA (DSQA) activities as required
- Participate in vendor audits and GCP Inspection Readiness activities related to systems
Cross-Functional Collaboration and Training
- Liaise between system vendors, study teams, and CROs on issue/CAPA/Deviation management related to UAT
- Develop and maintain study training materials (Study Guides, SIV slide decks) for system users
- Support user access management, training assignment, and access review for systems
- Provide SME Support for troubleshooting, system design review, and audit-inspection support for active and inactive studies
Position Requirements
Required:
- Bachelor’s degree in Life Sciences, Information Technology, Clinical Research, or a related field
- Minimum 3 years of experience in clinical trial operations, clinical systems, or computer system validation within the pharmaceutical or biopharmaceutical industry
- Demonstrated experience coordinating or executing UAT for GxP-regulated clinical systems (IRT, eCOA, CTMS, or similar)
- Working knowledge of GxP regulations applicable to clinical trial technology systems, including 21CFR Part 11, ICH E6 (GCP), and EU GMP requirements
- Familiarity with IRT system functionality (randomization, trial supply management, subject management) and/or eCOA system functionality (in-clinic and at-home patient reported outcomes)
- Strong organizational skills with the ability to manage multiple concurrent UAT activities across studies and vendors
- Proficiency with electronic document management systems (e.g., Veeva Vault Quality Docs, Veeva Vault Clinical eTMF)
- Excellent written and verbal communication skills; ability to produce clear, audit-ready documentation
Preferred:
- Experience with IRT and eCOA systems/platforms
- Experience with DocuSign (21CFR Part 11-compliant electronic signatures)
- Familiarity with CSV methodology and SDLC documentation
- Experience supporting GCP inspections or vendor audits
- Knowledge of TMF Reference Model and eTMF filing requirements
Key skills/competency
- Clinical Systems Associate
- User Acceptance Testing (UAT)
- GxP-regulated clinical systems
- Clinical trial operations
- IRT systems
- eCOA systems
- Computer System Validation (CSV)
- Veeva Vault
- 21 CFR Part 11
- ICH GCP
Skills & topics
- Clinical Systems Associate
- Clinical Systems
- UAT
- GxP
- IRT
- eCOA
- CSV
- Veeva
- Clinical Operations
- Pharmaceutical
- Biotech
- Remote
- Validation
- Compliance
- 21 CFR Part 11
- ICH GCP
How to get hired
- Tailor your resume: Highlight GxP systems, UAT coordination, and clinical trial operations experience, using keywords from the job description like IRT, eCOA, and CSV.
- Quantify achievements: Use numbers to demonstrate impact, such as the number of studies supported or issues resolved, in your application.
- Showcase system knowledge: Emphasize familiarity with GxP regulations (21 CFR Part 11, ICH GCP) and specific systems like Veeva Vault.
- Prepare for behavioral questions: Be ready to discuss your organizational skills and cross-functional collaboration experience, providing specific examples.
Technical preparation
Study GxP regulations: 21 CFR Part 11, ICH GCP.,Understand IRT and eCOA system functionalities.,Practice UAT planning and execution.,Familiarize with Veeva Vault and eTMF.
Behavioral questions
Describe a complex UAT issue you resolved.,How do you manage multiple study timelines?,How do you collaborate with vendors and teams?,Give an example of ensuring data integrity.
Frequently asked questions
- What are the primary responsibilities of a Clinical Systems Associate at KPS Life?
- The Clinical Systems Associate at KPS Life is primarily responsible for supporting User Acceptance Testing (UAT) and other clinical systems activities for global clinical trials. This includes planning, coordinating, executing, and documenting UAT for systems like IRT and eCOA, ensuring they are validated and compliant with GxP regulations before go-live.
- What specific clinical systems experience is required for this Clinical Systems Associate role?
- The role requires demonstrated experience coordinating or executing UAT for GxP-regulated clinical systems, with a strong emphasis on IRT (Interactive Response Technology) and eCOA (electronic Clinical Outcome Assessment) systems. Familiarity with CTMS and other similar systems is also valuable.
- Is this Clinical Systems Associate position remote?
- Yes, this Clinical Systems Associate position is dedicated remotely to support KPS Life's sponsor partners' global clinical trials.
- What GxP regulations are most important for this Clinical Systems Associate role?
- A working knowledge of GxP regulations applicable to clinical trial technology systems is crucial. This includes familiarity with 21 CFR Part 11, ICH E6 (GCP), and EU GMP requirements. Proficiency with electronic document management systems like Veeva Vault is also a key requirement.
- What kind of documentation is expected from a Clinical Systems Associate at KPS Life?
- The Clinical Systems Associate is expected to produce clear, audit-ready documentation for all UAT deliverables, including UAT Plans, Test Scripts, Summary Reports, and Approval Forms. This documentation must be maintained in systems like Veeva Vault Clinical eTMF and Veeva QualityDocs.
- How does KPS Life ensure systems are validated for clinical trials?
- KPS Life ensures systems are validated by having the Clinical Systems Associate coordinate and execute User Acceptance Testing (UAT) according to Computer System Validation (CSV) methodology and applicable SOPs. This involves aligning UAT activities with requirements, managing issues, and ensuring all documentation is accurate and complete.
- What are the preferred qualifications for a Clinical Systems Associate at KPS Life?
- Preferred qualifications include direct experience with IRT and eCOA systems/platforms, experience with DocuSign for electronic signatures, familiarity with CSV methodology and SDLC documentation, experience supporting GCP inspections or vendor audits, and knowledge of the TMF Reference Model and eTMF filing requirements.