Roles & Responsibilities Clinical Trial Document Preparation and Archiving Be familiar with the content of clinical trial master file and investigator site file based on the requirements of ICH GCP, China regulation and Roche SOPs, guidance. Support to prepare site file before study start up. Review the closed clinical trial documents, support archiving. responsible to arrange and archive them according to related SOP requirements. Business Support to Department. Understand ICH GCP, China GCP and related regulation on clinical trials. Support SSUS to prepare the essential EC submission package according to required timeline. Support SSUS on site budget and contract preparation. Maintains and analyzes study data (metrics) on assigned studies. Support. PDG China to identify opportunities for continuous improvement. Update and maintain the data in CDE platform according to regulatory and SOP requirements. Support local clinical operation data cleaning and management. General Office Duties Provide general office support to PDG China department staff (including but not limited to photocopying, distributing mail/faxes, scanning, faxing,). Organize courier services for documents/ goods pick-up. Help to arrange meetings or meeting logistics. Perform other tasks, as assigned by line manager. Qualification and Experience Education/Qualifications Bachelor degree or above Major in public health, data science, computer science, pharmacy, biology or related.