【Job responsibility】
1. Assist in the management of global clinical trial projects, including the monitoring of project progress, quality and budget implementation
2. Participate in the implementation of the overall clinical research plan and clinical trial plan; Participate in the screening and evaluation of clinical sites, CROs, etc.
3. According to the clinical trial plan, participate in the drafting of the project management plan; determine team members, financial budget, etc., and review and modify the project management plan in a timely manner
4. Assist in the management of quality and clinical management of clinical research projects, strict control the budget, and ensure the smooth progress of the trial project plan. Regularly report the progress of the test and complete the project progress report
5. Establish good relationships with investigators, clinical research institutions, CROs, SMOs and other suppliers; effective communication and coordination to ensure the smooth implementation of the project
6. Thorough understanding of the writing, review and finalization of relevant technical documents such as clinical trial protocols, original medical records, CRF, clinical trial operation manuals, laboratory operation manuals and clinical trial reports
7. Communicate and coordinate effectively with other personnel related to the project, such as medical writing, data management and statistics, etc.
8. Coordinate and complete the internal audit and quality assurance of clinical trial projects
9. Participate in the company's on-going projects and other related R&D work
【Job requirement】
1. Master's degree or above in clinical medicine, pharmacy and other related pharmaceutical majors; clinical management experience in global CRO or Biotech is preferred
2. Engaged in clinical trial research for more than 8 years, familiar with domestic and international drug research and development regulations, policies and the current status of clinical research and development in China and abroad
3. Excellent communication skills (English) and project management skills; good writing skills (Chinese and English). Good English communication skills are preferred;
4. Familiar with the process of clinical research and the work of all stages of clinical research; rich experience in managing clinical CRO (especially early clinical experience); work independently