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The Systems Analyst – Clinical Study Design and Analysis will collaborate with network and infrastructure administrators in the security-patching lifecycle and maintenance of the infrastructure supporting our business applications, safeguarding sensitive information and ensuring the uptime, performance, and security of IT infrastructure. In addition, the Systems Analyst will become subject matter experts in the Business Applications, and will manage and perform the routine regression-testing, as well as functional and non-functional testing for projects and enhancements.
Job Responsibility
Support, monitor, or execute the installation of infrastructure security patches and configuration changes, as necessary
Review system release notes and identify regression test requirements
Develop detailed test plans and strategies based on release notes, project requirements, and specifications documents
Perform manual and automated testing of software applications, including functional, regression, and performance testing
Document and report defects and issues identified during testing, and work with development teams to resolve them
Maintain detailed documentation of test/validation plans, test cases, and test results
Advise on the documentation of requirements to ensure that they are written in a testable manner
Validate that test scenarios meet feature acceptance criteria and customer expectations
Maintain and ensure the quality of documented user stories/requirements in tools such as Jira
Prepare, execute, document, and report validation protocols in line with GxP’s and other regulatory requirements and standards
Assure that all validation test procedures are in line with current technology, corporate, and governmental regulations
Perform Installation Qualification, Operational Qualification, and Performance Qualification validation on processes, equipment, and systems in conjunction with suppliers as appropriate
Requirements
Master’s degree OR Bachelor’s degree with 5- 9 years of experience in Information Systems Administration/Support/Validation
Experience with GxP-regulated computer system validation
Experience with Agile software development methodologies (Scrum)
Experience with validation solutions, tools, and methodologies
Nice to have
Experience drafting documentation in adherence to standard operating procedures
Understanding of biostatistical analysis methods
Experience with generative artificial intelligence, agentic AI, and other emerging technologies