Clinical Operations Manager
辉凌医药咨询（上海）有限公司
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2012-11-02
- 工作地点：北京-东城区
- 招聘人数：1
- 工作经验：八年以上
- 学历要求：本科
- 语言要求：英语精通
- 职位类别：医药技术研发管理人员
职位描述
Responsibilities:
1.Establish and manage a new clinical operations team of BDC in order to execute clinical trials in China or Asian region in supporting product registration.
2.Oversee the initiation and conduct of clinical trials either by Ferring's team or via CROs ensuring timely recruitment and finalization.
3.Prepare budgeting input for the planned clinical trials. To control the overall expenses of each clinical trial within predefined budget.
4.Select and manage suitable third party for out-sourced services (such as data management, statistical analysis, clinical research organization, central laboratories) necessary for the operation of clinical trial.
5.Identify suitable investigators and SFDA accredited sites. Establish and maintain good network with KOLs within key therapeutic areas.
6.Liaise with regional Clinical Science Manager/Clinical Research Physician on study design and statistical consideration in order to acquire clinical study protocol approvals from Global Clinical R&D.
7.Organize, initiate, monitor and manage clinical trials according to China Good Clinical Practice (cGCP) and ICH-GCP, Ferring's SOPs and other relevant clinical research guidelines.
8.Implement the Corporate SOPs, CTMS and REAL systems in BDC. Participate and support the development of local SOPs
9.Act as a Clinical Trial Manager as needed.
Requirements:
1.University degree in medicine, pharmacy or other life sciences
2.Minimal 7 years of international pharmaceutical industry experience in clinical study planning, execution activities as Clinical Trial Manager, or manager of clinical operations.
3.Good leadership skills and can inspiring other people
4.Strong insight of the overall drug development process, clinical trial methodology, China regulatory environment, ICH/GCP Guidelines and International regulations
5.Fluent in both English and Chinese.
6.Good communication and interpersonal skills - works well with others, motivates and encourages.Previous experience in personnel management or project management are preferable
7.Proficiency in computer skills, CTMS
1.Establish and manage a new clinical operations team of BDC in order to execute clinical trials in China or Asian region in supporting product registration.
2.Oversee the initiation and conduct of clinical trials either by Ferring's team or via CROs ensuring timely recruitment and finalization.
3.Prepare budgeting input for the planned clinical trials. To control the overall expenses of each clinical trial within predefined budget.
4.Select and manage suitable third party for out-sourced services (such as data management, statistical analysis, clinical research organization, central laboratories) necessary for the operation of clinical trial.
5.Identify suitable investigators and SFDA accredited sites. Establish and maintain good network with KOLs within key therapeutic areas.
6.Liaise with regional Clinical Science Manager/Clinical Research Physician on study design and statistical consideration in order to acquire clinical study protocol approvals from Global Clinical R&D.
7.Organize, initiate, monitor and manage clinical trials according to China Good Clinical Practice (cGCP) and ICH-GCP, Ferring's SOPs and other relevant clinical research guidelines.
8.Implement the Corporate SOPs, CTMS and REAL systems in BDC. Participate and support the development of local SOPs
9.Act as a Clinical Trial Manager as needed.
Requirements:
1.University degree in medicine, pharmacy or other life sciences
2.Minimal 7 years of international pharmaceutical industry experience in clinical study planning, execution activities as Clinical Trial Manager, or manager of clinical operations.
3.Good leadership skills and can inspiring other people
4.Strong insight of the overall drug development process, clinical trial methodology, China regulatory environment, ICH/GCP Guidelines and International regulations
5.Fluent in both English and Chinese.
6.Good communication and interpersonal skills - works well with others, motivates and encourages.Previous experience in personnel management or project management are preferable
7.Proficiency in computer skills, CTMS
公司介绍
辉凌医药咨询（上海）有限公司诚聘
联系方式
- 公司地址：杭州市