Clinical Project Manager
瓴路药业(上海)有限责任公司
- 公司规模:少于50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:2021-06-03
- 工作地点:上海-静安区
- 招聘人数:若干人
- 工作经验:5-7年经验
- 学历要求:本科
- 职位月薪:3-4万/月
- 职位类别:临床研究员
职位描述
Study Manager / Senior Study Manager (SM) is overall accountable for study operational deliverables and shall lead a study from the acceptance of Investigational New Drug (IND) or Clinical Trial Application (CTA) submission until the approval of final study results, the completion of authority inspection, or the end of the study, whichever comes later.
1 Execute and deliver assigned studies according to business needs (timeline and cost) and quality requirements as defined in the study protocol, local regulations, ICH-GCP, and Overland written process.
2 Lead assigned studies drive study-related decisions.
3 Serve as point-of-contact between Overland study team and vendor team.
4 Conduct risk-based quality control visits, implement CAPAs, and share lessons and best practices appropriately across sites and studies.
5 Escalate issues when required.
6 Senior SM and SM may act as mentor of associate SM.
任职要求:
Minimum of 3-year experience in the industry, with PM (or CTM in CROs) experience. Personnel with experience in global pharmaceutical companies or CROs are preferred.
必要的技能和能力
1.Familiar with GCP and relevant local regulations;
2.Able to manage competing priorities;
3.Pay high attention to details and accuracy;
4.Result driven;
5.Client-oriented;
6.Good in communication;
职能类别:临床研究员
公司介绍
联系方式
- 公司地址:地址:span望京利泽西街6号院东湖国际中心A座