ACRM-北京
葛兰素史克(中国)研发中心
- 公司规模:150-500人
- 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:2013-03-26
- 工作地点:北京
- 招聘人数:若干
- 工作经验:五年以上
- 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 临床研究员
职位描述
职位目的
To project manage the studies ensuring timeline, subject recruitment and quality/compliance targets are met
主要工作职责
1 Clinical operation responsibility:
1.1 Work with line manager on the plan for study budget, timeline, recruitment target and human resource
1.2 Prepare and execute co-monitoring plan and QA plan before the study start and ensure no significant compliance( GCP, SOP or applicable regulations) issue during the whole study
1.3 Ensure implementation of clinical research standard operating procedures for all clinical trials conducted in responsible area
1.4 Prepare project recruitment plan and ensure the target is met
1.5 Work out and implement contingency plan if need 1.6 Make study preparation activity such as
1.6.1 Prepare study documents such as protocol, ICF and CRF design
1.6.2 Site selection and organize or chair investigator meetings
1.6.3 Plan, order and track clinical supply
1.6.4 Evaluate, select and manage CROs
1.7 Ensure the eTrack data completeness and accurate during the whole study conduction
1.8 Perform initiation, monitoring and study close out tasks as required by GCP and SOPs
2 Provide training, coaching and consultation to the project team members
3. Maintain effective communication with internal and external contacts
3.1 Build up the close relationship with the “key” sites/investigators
3.2 Keep effective communication with the central team
申请资格
Knowledge & Experience
• Minimum bachelor degree in clinical medicine or Life/Biological Sciences
• Previous experience in clinical medicine, pharmaceutical and services industry is required
• 2 years clinical research experience is needed Skills
• Excellent command of English (written and spoken)
• Knowledge of PC (WORD, EXCEL, POWERPOINT)
• Interpersonal communication skill;
• Problem solving
• Planning & Project Management
To project manage the studies ensuring timeline, subject recruitment and quality/compliance targets are met
主要工作职责
1 Clinical operation responsibility:
1.1 Work with line manager on the plan for study budget, timeline, recruitment target and human resource
1.2 Prepare and execute co-monitoring plan and QA plan before the study start and ensure no significant compliance( GCP, SOP or applicable regulations) issue during the whole study
1.3 Ensure implementation of clinical research standard operating procedures for all clinical trials conducted in responsible area
1.4 Prepare project recruitment plan and ensure the target is met
1.5 Work out and implement contingency plan if need 1.6 Make study preparation activity such as
1.6.1 Prepare study documents such as protocol, ICF and CRF design
1.6.2 Site selection and organize or chair investigator meetings
1.6.3 Plan, order and track clinical supply
1.6.4 Evaluate, select and manage CROs
1.7 Ensure the eTrack data completeness and accurate during the whole study conduction
1.8 Perform initiation, monitoring and study close out tasks as required by GCP and SOPs
2 Provide training, coaching and consultation to the project team members
3. Maintain effective communication with internal and external contacts
3.1 Build up the close relationship with the “key” sites/investigators
3.2 Keep effective communication with the central team
申请资格
Knowledge & Experience
• Minimum bachelor degree in clinical medicine or Life/Biological Sciences
• Previous experience in clinical medicine, pharmaceutical and services industry is required
• 2 years clinical research experience is needed Skills
• Excellent command of English (written and spoken)
• Knowledge of PC (WORD, EXCEL, POWERPOINT)
• Interpersonal communication skill;
• Problem solving
• Planning & Project Management
公司介绍
葛兰素史克是最早在中国大规模投资研发领域的国际制药公司之一,通过与中国政府、学术机构和医疗专家保持密切的合作,致力于提高中国人民的健康水平。在进入中国的20多年间,我们在国内的药物研发和临床研究方面已投入了10亿元人民币。我们的目标是使中国成为葛兰素史克全球研发体系中一个重要的战略中心。
联系方式
- 公司网站:http://www.gsk.com
- 公司地址:上海市张江高科技园区哈雷路898弄3号
- 邮政编码:201203
- 联系人:HR