北京招聘

部门: 临床研发部门

职位名称: 临床监察主管

工作地点: 日健中外科技(北京)有限公司

1. 职位描述

与HQ一起协作和管理临床试验工作及第三方公司以保证临床试验按照公司SOP的试验方案、相关政策以及ICH-GCP原则进行。

1）管理临床试验工作（例如，选择临床试验基地、征集志愿者、SDV等）。

2）协助HQ制作临床试验方案。

3）与临床医生建立良好关系。

4）遴选临床试验相关的第三方公司（例如，CRO、临床实验室公司等）。

5）根据中国GCP及相关法规制作/修订GCP-SOPs。

2. 资格/经验要求

1）本科/硕士学位或同等学位/经验，有药学、生命科学或相关专业背景。

2）具有监管临床试验过程的经验，并有管理经验和/或管理工作的相关经验。

3）熟练掌握ICH GCP、中国GCP及临床试验管理的相关政策法规的知识。

4）充分理解项目管理过程。

5）具有良好的处理问题的能力。

6）具有较强的人员管理及沟通能力。

7）可熟练使用英语进行书写及口语表达。会日语者优先。

8）计算机能力。

Department: Clinical Research
Job Title: Study manager
Report to: Clinical Operation
Location: Chugai Pharma Science (Beijing) Co. Ltd


1. Purpose of the Job:
1）With strong capability to identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, Chugai SOPs, applicable regulations and the principles of ICH-GCP.
2）To coordinate and manage the activities of individual studies and site/CRO staff in a manner that ensures all timeframes and targets are met and that costs are kept under control.
3）To effectively manage assigned staff to ensure high performance, continuous development, and low turn over.


2. Qualifications/ Experience required:
1）University/Bachelor’s Degree or equivalent degree/experience and a background in medicine, science or other relevant discipline.
2）A satisfactory progression of monitoring experience with some experience in leadership and/or management activities and relevant experience.
3）Thorough knowledge of ICH GCP, China GCP and relevant regulations for the conduct of clinical trials.
4）Good understanding of project management processes.
5）Highly developed problem solving skills.
6）Strong people management and effective communication skills.
7）Fluent in written and spoken English. Additional language skills（Japanese） desirable.
8）Computer literate.