职责描述：

Job description:

1、负责临床试验项目运营与管理、监查报告的技术审核；

1. Be responsible for the operation and management of clinical trial projects and the technical review of monitoring reports;

2、从整体上分配和协调资源，把握项目进度，确保项目在预算时间和成本内优质高效完成；

2. Allocate and coordinate resources as a whole, grasp the project progress, and ensure that the project is completed with high quality and efficiency within the budgeted time and cost;

3、负责项目管理部的营运及日常管理、绩效考核、技术指导和培训；

3. Be responsible for the operation and daily management, performance appraisal, technical guidance and training of the project management department;

4、负责部门管理制度及SOP的制定、监督执行；

4. Be responsible for the formulation, supervision and implementation of department management system and SOP;

5、完成总经理交办的其他工作。

5. Complete other tasks assigned by the general manager.

任职要求：

Job requirements:

1、硕士学历，临床医学、药代动力学、生物药剂学等相关专业；

1. degree, major in clinical medicine, pharmacokinetics, biopharmaceutics, etc;

2、8年以上国际或国内大型药企、CRO公司类似岗位任职经历；

2. At least 8 years working experience in similar positions in large international or domestic pharmaceutical enterprises and cro companies;

3、丰富的创新药I&II&III期项目管理、监查或稽查经验，熟悉ICH/GCP、FDA/CFDA有关临床试验的相关法规；

3. Rich experience in management, supervision or inspection of innovative drugs phase I & II & III projects, and familiar with relevant regulations of ICH / GCP and FDA / CFDA on clinical trials;

4、具有较强的领导能力、判断能力和沟通能力、应变能力；

4. Strong leadership, judgment, communication and adaptability;

5、具有良好的英文听说和写作能力；

5. Good English listening, speaking and writing skills;

6、强烈的事业心与使命感、持续的自我驱动力、个性阳光、开朗。

6. Strong dedication and sense of mission, continuous self driving force, sunny personality and cheerful.