Responsibilities and Duties:
主要职能 Primary Function:
Responsible for analyzing and implementing system solutions to enable Clinical Operations to reduce costs and enhance operational efficiency and serving as Super User for clinical operation systems (e.g., CTMS, Site Payments) with accountability for maintenance, user support, data integrity, and process standardization.
主要职责 Major Responsibilities and Duties:
Act as the System Super User, ensuring clinical operation systems (e.g., CTMS, Site Payments) configuration and setup consistently comply with Zai Lab internal SOPs and governance requirements.
Develop, maintain, and enhance systems to track study status and process compliance, incorporating business team feedback to improve workflows and monitoring capabilities in a timely manner.
Serve as System Specialist, providing support, system updates, troubleshooting, and guidance to end users.
Lead vendor selection and management, overseeing related system issues.
Manage clinical operation systems related Q&A.
Study Set up and templates allocation.
Generate and provide metrics, status updates, trend analyses, and other relevant reports as needed.
Develop, maintain, and deliver training materials to enhance end users’ knowledge and effective use of clinical operation systems.
Qualifications:
任职要求 Qualifications:
At least 5 years working experience in clinical trials or system maintenance and management, CTA, CRA, Project Manager or IT engineer. Previous working with CTMS and/or eTMF system is preferable.
Excellence communication skill, good in English reading and writing. Interpersonal skill and presenting skill in front of cross function audience is a prior.
Bachelor’s degree in medicine, nursing, pharmacology, pharmaceutical science, or IT etc.
Experience with agentic AI development platforms and RPA platforms will be considered a plus.
Proven project management and delivery experience; PMI Project Management Certification preferred.