Clinical APM

2025-04-29

Responsibilities:

1. Comprehensively manage, control and supervise the project quality in accordance with the Drug Registration Administration Measures and GCP and other clinical trial regulations, and ensure the quality of the project delivery on time;

2. Responsible for the project team's CRA business guidance and implementation;

3. Assisted the department manager to improve the department system and SOP upgrade, and supported the smooth implementation of the new system;

4. Responsible for training related to CRA projects;

5. Carried out project cost management, controlled unnecessary expenses and reviewed CRA's inspection plan;

6. Coordinated the relationship among research centers, sponsors, data management and statisticians, and maintained good communication.

Job Requirements：

1.Bachelor degree or above, major in medicine, biology or related;

2.At least 3 years working experience in CRA; At least 1 year of clinical trial management experience in tumor and metabolism (macromolecular biologics);

3. Foreign company experience or overseas background is preferred;

4. Familiar with drug registration management methods, GCP laws and regulations, and the whole process of clinical research;

5. Strong ability of management, organization, coordination and problem solving;

6. Excellent planning and execution ability;

7. Strong sense of responsibility and strong ability to work under pressure.