Clinical Research Manager
上海仕璞企业管理咨询有限公司
- 公司规模：少于50人
- 公司性质：民营公司
- 公司行业：专业服务(咨询、人力资源、财会) 制药/生物工程
职位信息
- 发布日期：2013-01-09
- 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：普通话精通
英语精通 - 职位类别：生物工程/生物制药
职位描述
Duties and Responsibilities
1.Communicate with client while whole trial life to gain support and experiences to facilitate of clinical studies. Organize and or coordinate clinical studies and oversee progress and quality
2.Organize and or coordinate study initiation including protocol/CRF/ICF/diary card development, PSV, PI/site selection, CRO training 3.Organize investigator meetings and trainings, oversee all related preparation including administrative issues such as material printing, labeling & packaging and other logistic affairs
4.Prepare Investigator Package Plan and training for CRO and or CRAs
5.Review and approve EC submission to IRBs, and IP for each site
6.Monitor and guide CRO and or CRAs to ensure the study progress and quality
7.Conduct co-monitoring visits, close-out visits
8.Coordinate with CRO and or CRAs to follow up the audit findings till nothing remaining
9.Support medical writing of study protocol and clinical study report
10.Support regulatory submission to SFDA on clinical overview/reports
11.Support sales/marketing/BD departments' on medical opinion
12.Manage clinical team and giving proper training according to SOPs
Qualifications
- Master degree or above prefer on medical or pharmacy.
- At least 4 years' experience in clinical trials including site management, project management and etc.
- Familiar with ICH and Chinese GCP and related guidelines.
- Result oriented.
- Customer focus and teamwork.
- Organizational commitment.
- Good communication skill.
- Good at English writing and speaking
1.Communicate with client while whole trial life to gain support and experiences to facilitate of clinical studies. Organize and or coordinate clinical studies and oversee progress and quality
2.Organize and or coordinate study initiation including protocol/CRF/ICF/diary card development, PSV, PI/site selection, CRO training 3.Organize investigator meetings and trainings, oversee all related preparation including administrative issues such as material printing, labeling & packaging and other logistic affairs
4.Prepare Investigator Package Plan and training for CRO and or CRAs
5.Review and approve EC submission to IRBs, and IP for each site
6.Monitor and guide CRO and or CRAs to ensure the study progress and quality
7.Conduct co-monitoring visits, close-out visits
8.Coordinate with CRO and or CRAs to follow up the audit findings till nothing remaining
9.Support medical writing of study protocol and clinical study report
10.Support regulatory submission to SFDA on clinical overview/reports
11.Support sales/marketing/BD departments' on medical opinion
12.Manage clinical team and giving proper training according to SOPs
Qualifications
- Master degree or above prefer on medical or pharmacy.
- At least 4 years' experience in clinical trials including site management, project management and etc.
- Familiar with ICH and Chinese GCP and related guidelines.
- Result oriented.
- Customer focus and teamwork.
- Organizational commitment.
- Good communication skill.
- Good at English writing and speaking
公司介绍
上海仕璞企业管理咨询有限公司 诚聘
专业提供医药行业咨询服务
简历投递：nickeyzhu@searchpple.com
地址：上海浦东张杨路828号华都大厦3F(2 4 6 9 世纪大道地铁站12号口3分钟）
专业提供医药行业咨询服务
简历投递：nickeyzhu@searchpple.com
地址：上海浦东张杨路828号华都大厦3F(2 4 6 9 世纪大道地铁站12号口3分钟）
联系方式
- Email：nickeyzhu@searchpple.com