岗位职责：

1. 负责临床试验项目的运营管理，包括第三方公司、临床中心筛选、项目启动、受试者招募、试验推进、数据收集、药物管理及不良事件报告等；

2. 负责企业原创新药临床试验的组织与实施工作，包括但不限于负责公司Ⅰ、Ⅱ、Ⅲ、Ⅳ期临床试验的项目管理工作，确保所有试验严格按照临床试验方案、标准操作程序/内部操作流程和中国法规进行；

3. 运营维护与研究者、临床中心的良好关系，及时向研究者传递公司的重要信息；

4. 参与临床试验方案撰写及相关技术资料，如CRF、伦理及遗传办备案材料、试验进展报告、总结报告等；

5. 制定研究项目执行计划，审核CRO、临床机构以及第三方供应商的报价和预算，对临床试验过程中可能出现的问题进行预判，并制定临床研究应对预案，对项目进行全面的质量控制与管理，按时完成临床试验的启动、执行及结束工作；

6. 负责与上级领导和CRO及时沟通，选定试验中心、研究者并汇总制定项目费用预算，监督指导CRO公司按照公司、GCP及相关法规要求完成试验；

7. 定期召开与第三方公司的沟通会议，如CRO、SMO、药品生产、样本检测、数据统计等，做好第三方公司的实时监管，确保试验质量；

8. 负责所有的项目相关文件、物资及药品调配，与CRA和上级领导及时沟通不良事件，物资，时间点及财务预算等相关内容；

9. 向公司决策层提供相关竞品临床及上市信息，为临床方案撰写及临床研究提供支持；

10. 制定和完善临床部门的管理制度和操作规程（SOP），负责制定部门建设计划及预算，经公司批准后按计划组建团队及组织培训；

11. 协助新药注册申报工作，及时了解与临床研究相关的各项法规，根据临床研究需要向非临床团队提供相应支持；

12. 领导交办的其他任务。

资格要求：

1. 临床医学、药学等相关专业硕士及以上学历，有海外留学或工作经历者优先；

2. 5年以上临床试验项目管理经验，熟悉临床试验管理规范，有肿瘤、免疫治疗领域经验优先；

3. 稳重细心、责任感强、善于沟通、抗压能力强，很好的逻辑性及组织能力；

4. 具有良好的人际交流能力，能够与公司内部各部门及合作方进行良好沟通交流；

5. 具有良好的团队组织及建设能力；

6. 良好的英文写作和听说能力；

7. 能够接受不定期出差；

Job Responsibilities:

1.Responsible for the operation and management of clinical trial projects, including third party companies, clinical center screening, project initiation, subject recruitment, trial advancement, data collection, drug management and adverse event reporting, etc.;

2.Responsible for the organization and implementation of clinical trials of innovative drugs, including but not limited to project management of Phase I, II, III and IV clinical trials, ensuring that all trials are conducted in strict accordance with clinical trial protocols, standard operating procedures/internal operating procedures and Chinese regulations;

3. Operating and maintaining good relationships with investigators and clinical centers and communicating important company information to investigators on time;;

4.Participate in clinical trial protocol writing and related technical documents, such as CRF, ethics and genetic office filing documents, trial progress reports, summary reports, etc.;

5.Develop research project execution plans, review quotations and budgets from CROs, clinical institutions and third-party suppliers, anticipate possible problems during clinical trials and develop clinical research response strategies, conduct comprehensive quality control and management of the project, and complete the initiation, execution and closure of clinical trials on time;

6.Responsible for communicating with senior leaders and CROs promptly, selecting trial centers and investigators as well as summarizing and formulating project cost budgets, supervising and guiding CROs to complete trials in accordance with company, GCP and relevant regulatory requirements;

7. Hold regular communication meetings with third-party companies, such as CRO, SMO, drug manufacturing, sample testing, data statistics, etc. Provide effective supervision of third party companies in real time to ensure the quality of trials;

8. Responsible for all project related documents, materials and drug deployment, keep communicating with CRA and higher management on adverse events, materials, schedule and financial budget and other related contents;

9. Provide relevant competitive clinical and marketing information to the company's decision-making level, and provide support for clinical protocol writing and clinical research;

10.Develop and improve the management system and operation procedures (SOP) of the clinical department, and be responsible for the development of departmental construction plan and budget, forming the team and organizing training according to the plan after approval by the company;

11. Support new drug registration declaration, keep abreast of regulations related to clinical research, and provide corresponding support to non-clinical team according to clinical research needs;

12. Other tasks assigned by the supervisor.

Qualification Requirements:

1. Master's degree or above in clinical medicine, pharmacy or other related majors, overseas study or work experience is preferred;

2. More than 5 years experience in clinical trial project management, familiar with clinical trial management regulations, with experience in oncology and immunotherapy field is preferred;

3. Steady and careful, strong sense of responsibility, good communication skills, strong anti-stress ability, very good logic and organizational skills;

4. Good interpersonal communication skills, able to communicate well with various departments within the company and with partners;

5. Good organizational and team building skills;

6. Excellent English writing and listening skills;

7. Willing to take irregular business travelling.