Premier Research
• $100K *Qualifications
Responsibilities
Benefits
What You'll Be Doing:
Lead and/or support users, developers, and administrators in developing user requirements, design/functional specifications, and system test plans/scripts, including guidance on execution and documentation of test scripts
Identify, plan, and schedule project deliverables, milestones, and tasks required to validate/UAT software releases; research, develop, and write validation/UAT content
Provide guidance on SDLC documentation creation/review, and prepare/maintain documentation relating to users, systems, programming, operations, products, services, testing, and validation, including graphical images, flow charts, and diagrams
Lead and/or participate in developing SOPs to ensure regulatory compliance, and ensure adherence to SOPs, regulatory validation, and quality assurance plans by software developers and customers
Act as independent quality reviewer for peer software validations while remaining open to critical review of own work, ensuring project validation documentation meets all project and SOP requirements to support audits
Advise IT resources/business SMEs and maintain systems validation documentation; lead/consult on ongoing operational/risk assessment activities (change management, admin/maintenance reviews, periodic reviews); up to 20% overnight travel required
What We Are Searching 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 2-4 years direct experience managing low to moderate scope systems validation projects through all aspects of project life cycle, or 4-6 years of relevant experience in systems validation with a CRO, Biotech, Pharma
Experience in at least one generally accepted standard for software/system development, service delivery, and validation methodologies (i.e. PDA, GAMP, ISO9000, IEEE, ITIL, CobIT)
Proven track record of test script developmenttechnologies including unit, functional, performance, capacity, stress, and installation
Solid experience gathering and writing functional and system requirement documentation, pseudo logic, risk assessments, traceability matrices, bug tracking, validation plans, final reports, system support documentation
Familiarity with/experience in the following systems/supporting systems a plus: Data Integration Platforms, ERP, Clinical Systems, Networks and Infrastructures
Current working knowledge of current GxP and European Union regulations as they pertain to computerized systems
Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $100,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.
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