1. Develop plans and budgets for clinical trial projects, and manage project costs effectively;
2. Screen clinical trial centers, organize clinical trial meetings, and keep good communication and collaboration with research centers and experts;
3. Organize the preparation of project clinical plans and other related materials;
4. Organize the preparation of SOP documents, risk management plans, summary reports, and other materials about clinical trials;
5. Develop the quality management plan for clinical trials, and assist in audits and verifications;
6. Create schedule plans, break down tasks, and ensure effective implementation of the schedule plan;
7. Coordinate the completion of clinical trial data verification and statistical analysis;
8. Develop project communication plan and monitoring plan. Establish and maintain internal/external relations related to the project;
9. Provide guidance on project-related work to inspectors, and conduct preliminary performance evaluation of them.
1. Bachelor's degree or above in fields such as clinical medicine, clinical pharmacy or nursing.
2. Over 10 years of experience in clinical management.With experience in CE or FDA clinical project management.
3.Fluet in English in listening, speaking,reading and writing,which can be used as working language. Overseas study/work experience is preferred.
4.Accept long-term business trip in Europe or the United States if based domestically.
5.Familiarity with European/American medical device GCP regulations and clinical trials.
6.Strong leadership skills, excellent interpersonal & social skills.
7.Effective coordination & communication abilities, and strong sense of responsibility & dedication.
8.Quick learning & review and summarize ability.