(高级)临床数据管理员
恒瑞医药-上海盛迪医药有限公司
- 公司规模:10000人以上
- 公司性质:民营公司
- 公司行业:制药/生物工程
职位信息
- 发布日期:2021-01-12
- 工作地点:上海-浦东新区
- 招聘人数:2人
- 工作经验:1年经验
- 学历要求:本科
- 语言要求:英语精通
- 职位月薪:1-2万/月
- 职位类别:临床数据分析员
职位描述
Responsibilities
1. As the DM point of contact in the study team, responsible for communication and coordination.
2. Review study protocol and provide input from DM perspective.
3. Review DMP and DVP
4. Review CRF entry guideline
5. Review data transfer agreement
6. Design eCRF and facilitate team review for approval
7. Create and maintain EDC development timeline, and ensure database go-live with good quality per timeline
8. Deliver EDC training to study team
9. Create plans for data cleaning, and ensure data with good quality for statistical analysis
10. Review coding result and facilitate discussion with medical team
11. Provide study status report to the study team, and follow up pending issues
12. Prepare materials for data review meeting
13. Data extract and transfer
14. Create Data Management Report
15. Database and documents archival
16. CRO oversight in outsourced study
Competencies
1. Good logical thinking and communication skills
2. Good problem solving skills
3. Good multi task and time management skills
4. Good team player
5. Able to work under pressure in an competitive environment
6. Good understanding of drug development life cycle
7. Familiar with GCP and data management related regulations
8. Global projects experience is a must
公司介绍
上海盛迪医药有限公司是江苏恒瑞医药股份有限公司的全资子公司,公司位于上海浦东张江高科技园区,注册成本2.5亿元,占地面积14000平方米。上海盛迪作为恒瑞新药研发的重要组成部分,下设临床医学、中央医学事务、中央市场、临床前开发、新药协调、商务发展、转化医学、对外研发合作等核心职能。
联系方式
- 公司地址:上海浦东新区 (邮编:201210)
- 电话:19551398868