Clinical Operation/Project Management

1. Fully responsible for the implementation and management of the company's clinical trial projects, developing product clinical development strategies and clinical plans, and promoting the success of clinical trials; Interpret relevant clinical data and participate in the development of the company's new technology and product transformation research strategies;

2. Organize the development of clinical research project budgets and implementation plans, be responsible for the full process management of clinical trials, solve difficulties in the promotion of clinical research projects, and ensure the smooth implementation of clinical research projects;

3. Responsible for organizing the development of clinical research project management related systems, processes, and SOP documents, and supervising their implementation; Ensure that the experimental projects are strictly conducted in accordance with the plan, SOP, and relevant regulations;

4. Responsible for the progress and quality of clinical research projects, conducting regular/phased evaluations, and regularly reporting project progress to the company;

5. Professional communication with clinical experts, researchers, and reviewers to provide scientific and regulatory support for clinical research design;

6. Responsible for conducting self inspection and verification of NMPA clinical research projects after NDA application, ensuring smooth on-site verification of clinical trial projects;

7. Manage partners, including CROs and SMOs, to coordinate and supervise the progress of clinical trials;

8. Fully responsible for the management of the IIT project, including the writing of trial protocols/CRFs/informed consent forms, project initiation, ethical application, coordination and communication between the research center and sponsors, etc;

Requirements

1. Major in clinical medicine, nursing, biomedical engineering, biology or related fields, with a bachelor's degree or above, more than 5 years of work experience, and more than 2 years of management experience;

2. Have good knowledge of GCP and clinical trial regulations, experience in clinical protocol design and medical device development plan design;

3. Strong sense of work responsibility, communication and coordination skills, strong ability to withstand pressure, and the ability to handle emergencies;

4. Rigorousness in work, strong logical thinking, communication and adaptability, leadership skills in cross departmental work, adaptability to fast-paced work, strong execution ability and good teamwork spirit.