1. Plan and manage clinical trial development projects for drugs under research, lead and manage various functional members of the clinical trial team, and promote Phase I, II, III, and subsequent clinical trials;

2. Responsible for evaluating the feasibility of project operations, planning time, resources, and budgets, and formulating outsourcing strategies and selecting suppliers for designated projects;

3. Responsible for reviewing the feasibility assessment and project plan provided by CRO;

4. Supervise CRO, provide optimization suggestions in a timely manner, ensure that the study is executed according to the contract plan, accurately and timely track and report various operational indicators, organize and review the trial documents required for the project (including clinical hospitals);

5. Supervise the operation of clinical trials to ensure compliance with quality standards, including the pharmaceutical regulations of the country where the trial is conducted and the current ICH GCP guidelines;

6. Effectively identify, communicate, and mitigate project status, risks, and changes that may affect quality, timeline, and cost;

7. As required, be responsible for continuous review of all study documents (IB, protocol revisions, reports, etc.), informed consent forms, case report forms, adverse event descriptions, study materials, and monitoring tools;

8. Review data in the clinical trial database, identify abnormal results, assess clinical significance, determine any efficacy and/or safety trends, and determine whether specific action measures are needed;

9. Coordinate and attend internal and external clinical project communication meetings, prepare meeting agendas and minutes;

10. Complete other related tasks assigned by superiors.

1. Bachelor’s degree or above in clinical medicine, pharmacy, biology, or related fields;

2. 4 years of experience in the pharmaceutical industry, 2 years of clinical project management experience, familiar with clinical research-related skills and legal and regulatory knowledge, experience in foreign companies is preferred;

3. Possess in-depth knowledge of the therapeutic field, research protocols, and data statistics;

4. Good oral and written communication skills in Chinese and English, goal-oriented management ability;

5. Good work experience and performance in clinical trial design and execution in multiple regions, especially FDA.

1. Assist in clinical trial design and selection of drug indications;

2. Assist CRO in preparing clinical trial protocols, investigator brochures, case report forms, and project-related medical document materials;

3. Establish and maintain medical cooperation relationships with Key Opinion Leaders (KOLs) and collect medical insights in the field/product.

1. Bachelor’s degree or above in clinical medicine, clinical pharmacy, or related fields, with 2 years of clinical medical experience in pharmaceutical companies or clinical work experience as a physician;

2. Familiar with the “Drug Administration Law,” “New Drug Approval Measures,” ICH-GCP, the entire process of drug R&D, proficient in the entire process of clinical trials, familiar with the development and current status of domestic and international clinical research;

3. Comprehensive knowledge of clinical trial management standards and ability to execute related training and quality control;

4. Ability to independently consult relevant literature and write various reports;

5. Good oral and written communication skills in Chinese and English.