面議(經常性薪資達4萬元或以上) 新北市汐止區 3年工作經驗 1天前更新
【Job Description】
A Clinical Systems Engineer supports the customization and configuration of our proprietary Java-based Medical Imaging platform. This system integrates with medical imaging viewers, supports edit checks, and underpins critical clinical trial workflows. The ideal candidate will combine deep software engineering expertise with an understanding of clinical data processes and regulatory requirements.
【Essential Duties and Responsibilities】
• Customize and configure eCRFs, edit checks, and workflow logic within a Java-based clinical data platform.
• Integrate imaging viewer components and support independent review workflows.
• Collaborate with Clinical Data Managers, Imaging Scientists, and Product Owners to align system behavior with study protocols and Independent Review Charters.
• Ensure compliance with GxP, 21 CFR Part 11, and internal validation standards.
• Provide technical leadership, code reviews, and mentorship to junior developers.
• Troubleshoot production issues and support system enhancements in a regulated environment.
【Qualifications and Skills】
• Strong proficiency in Java, Spring MVC, Oracle PL/SQL, and related frameworks.
• Experience with system integration, data modeling, and backend configuration.
• Familiarity with clinical trial workflows, eCRF design, and edit check logic.
• Understanding of regulatory requirements (e.g., GxP, 21 CFR Part 11).
• Excellent problem-solving, communication, and stakeholder engagement skills.
• Agile/Scrum experience preferred.
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