Systems Validation Analyst II Level 1

Premier Research is looking for a Systems Validation Analyst II Level 1 to join our IT & Corporate Administration team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. The Systems Validation Analyst performs business analysis, systems validation, and testing processes required to support the software development and implementation processes for both regulated and non-regulated systems. Responsibilities include working closely with business subject matter experts to define and document requirements and business processes that drive the features in the software used to support various segments of the clinical trials process. This position also directs validation/user acceptance testing ensuring final outcomes meet specified requirements. Lastly, this position ensures and facilitates corporate compliance with applicable regulations as they affect software development, implementation, and maintenance in a regulated environment. This includes participation in customer audits (e.g., supporting documentation requests). What you'll be doing: Work with users, developers, administrators to develop/assist in the development of: User requirements/design/functional specifications, system test plans/test scripts; assist users in the execution and documentation of test scripts Participate in ongoing operational/risk assessment activities such as change management, admin/maintenance reviews/monitoring, periodic reviews, etc. Research, develop, and write content for the validation/UAT of software products and services Act as an independent quality reviewer for peer and/or vendor created documentation What we are looking for: Bachelor's degree, or international equivalent, in Computer Science/Information Technology, Business Management Information Systems, or related discipline, or equivalent relevant experience BS degree and 4-6 years direct experience managing systems validation projects through all aspects of the project life cycle in a CRO and/or pharmaceutical environment, or 6-8 years of relevant experience in systems validation (e.g. Business Analyst, Validation Analyst) Experience in at least one generally accepted standard for software/system development, service delivery, and validation methodology (e.g., GAMP, ISO9000, ITIL Apply To This Job