Clinical PM/APM

2023-06-06

Responsibilities

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

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

3. Assist the department manager to improve the department regulations and upgrade SOP, and support the smooth implementation of the new regulations;

4. Responsible for training related to CRA projects;

5. Manage project cost, control unnecessary expense, review CRA inspection plan;

6. Coordinate the relationship among research centers, sponsors, data management and statisticians, and maintain good communication.

Job requirements

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

2.At least 3 years working experience in CRA and 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 the Drug Registration Administration Measures, GCP and relevant regulations, and the whole process of clinical research;

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

6. Excellent planning and execution ability;

7. Strong conscientiousness and strong ability to work under pressure.