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Yale University

Research university in New Haven, CT

IT – Business Systems Analyst 3 - Computer Systems Validation Specialist

Enterprise ApplicationsPosted on Nov 13
Full-timeRemote in USA$86.3k - $129.4kRemote

About the Job

Requirements

  • A bachelor's degree and four years of experience, or equivalent education and experience.
  • Strong analytical, critical-thinking, and problem-solving skills.
  • Developed interpersonal, written, communication, presentation, and organizational skills.
  • Proven ability to lead and manage staff.
  • Expertise with systems and process analysis methods and techniques.
  • Project management skills and knowledge of commonly used concepts, practices, and procedures.

Responsibilities

  • Plan, develop, execute, and document computer systems validation activities for clinical research applications, including validation plans, test protocols, and reports, consistent with institutional policies and applicable regulatory requirements.
  • Work with research teams, system owners, and Research Compliance/HRPP to document system requirements, intended use, acceptance criteria, and validation needs.
  • Coordinate validation schedules, risk assessments, and testing with HSIT, ITS, YNHHS DTS, and application owners, including assessment of system changes and maintenance of validation documentation.
  • Analyze test results against defined acceptance criteria, investigate deviations, and coordinate corrective actions with technical teams and system owners.
  • Develop and maintain validation procedures, workflows, and records to improve consistency, efficiency, and audit readiness. Provide documentation and technical support for internal and external audits.
  • Support configuration and testing of electronic data capture and related research applications, and administer Kneat or other designated validation tools.
  • Perform a diverse range of analytical duties in the development of technology solutions for business processes.
  • Plan, organize, and define requirements, methods, and end-user objectives, and coordinate effort with team members, other IT staff, users, and vendors.
  • Interview, analyze, and document end-user processes and systems requirements for enhancements, workflow improvements, or new system development.
  • Develop and execute system test plans to ensure application performance aligns to specifications.
  • Prepare technical reports and design workflow maps or other documents to facilitate understanding of systems.
  • Lead segments of larger projects and develop trainings, presentations, and communications.

About the Company

Yale University

Research university in New Haven, CT

Yale University is a private research university in New Haven, Connecticut. It provides undergraduate, graduate, and professional education alongside research, scholarship, and public engagement.

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