1. Daily management of the Clinical Verification Department, including department work plan, budget formulation, cost management and other daily document review and employee performance appraisal, personnel arrangement, team building and other management work.

2. Participate in planning, formulation, and implementation of the standard operating procedures of the Clinical Verification Department to ensure that they comply with the quality management specifications, policies and regulations, and international standards of drug clinical trials. And be responsible for the quality review of the above-mentioned related documents and processes.

3. Participate in the planning and implementation of project self-inspection, institutional quality control, project audit, and regulatory department audit in clinical trials.

4. Responsible for planning and implementing project audits, completing audit reports, and following up on the implementation of corrective and preventive measures.

5. Regularly conduct clinical quality on-site visits, formulate and lead the self-inspection of clinical trials, and complete relevant reports.

6. Responsible for the training of the Clinical Verification Department, provide training on clinical trial quality compliance; and summarize the problems found in clinical trial quality on-site visits, self-inspection, and audits, and provide corresponding training.

7. Coordinate, prepare and support on-site inspections conducted by regulatory authorities, and participate in other related management and technical support work for clinical trials.

8. Assist and coordinate the Medical Affairs Department, Clinical Project Department, and the Company's Compliance and Registration Department to deal with quality issues in clinical trials.

1. Bachelor degree or above, majoring in medicine, pharmacy, life sciences, etc.

2. More than 5 years of clinical trial-related work experience, at least 1 year of manager-level experience (such as project manager, line manager, quality manager or training manager, etc.), and experience in writing registration application materials.

3. Familiar with policies and regulations related to clinical trials (such as policies and regulations, drug clinical trial quality management standards, and relevant guidelines).

4. Good verbal and written communication skills, including communication and coordination skills with internal and external parties and partners.

5. Be proactive in work, have strong stress resistance, and adapt to business trips.