Job Responsibilities:

1.Responsible for the project management of clinical trials, overall quality control and schedule management of the clinical research projects responsible, collaborate with CROs to ensure that all trials are executed and completed in strict accordance with the clinical trial protocol, GCP and relevant regulations;

2. Develop project schedules and collaborate with CROs to complete the full initiation, execution and completion of the trial as planned, and communicate and coordinate effectively with other project related professionals, such as medical experts, data and statistics, as needed, to ensure timely maintenance of all required documentation;

3. Estimate project budgets, review and assess the service quotations from CROs in terms of content and cost; track expenditures during project execution and assess the reasonableness of cost increases to ensure that overall project expenditures are within budget;

4.Identify, monitor and respond to various risks in the project process, correctly assess the overall impact of the corresponding risks in the project, and propose feasible solutions or plans for known or potential problems and risks in the project;

5. Participate in and co-manage the preparation of documents and review of related documents for the CRO's project preparation, ethics and genetic office, and coordinate the organization of project initiation meetings;

6.Coordinate and manage the contract research organization (CRO) to control the project schedule nodes, promptly identify or anticipate problems that may cause project delays, report to the supervisor and propose solutions or recommendations in time;

7. Manage suppliers and coordinate with all parties involved in the trial (including transportation companies, central laboratories, storage companies, etc.) to ensure that trial supplies are adequate and promptly replenished and ensure prompt access to drugs and materials for clinical centers; report project progress to company leadership on a regular basis;

8. Maintain knowledge updates so that the execution of clinical trials is in compliance with the current GCP and other current laws and regulations, and ensure that all actions are in compliance with the company's rules and regulations.

9. Clinical market research and analysis of new projects, and other work related to the clinical project;

10. Other tasks assigned by the supervisor.

Qualification Requirements:

1. Bachelor's degree or above in pharmacy, clinical medicine or related field;

2. More than 5 years of clinical management experience, preferably responsible for more than 2 complete and rigorous clinical trial project management experience;

3. Rich knowledge of basic clinical research related knowledge and laws and regulations, familiar with domestic and international drug registration regulations, GCP and clinical related technical guidelines;

4. Excellent planning, organizing and problem solving skills, able to follow SOP requirements at all times, able to think independently and provide assistance for process improvement;

5. Familiar with drug targets, disease biology, and in-depth understanding of one or more disease areas is preferred;

6. Good communication and willingness to work as part of a team;

7. Excellent command of written and spoken English.