临床数据管理经理Clinical Data Manager
Guangzhou Andala Co.ltd.
- 公司规模：500-1000人
- 公司性质：外资(欧美)
- 公司行业：多元化业务集团公司
职位信息
- 发布日期：2019-11-14
- 工作地点：广州
- 招聘人数：1人
- 工作经验：2年经验
- 学历要求：本科
- 职位月薪：2-2.5万/月
- 职位类别：临床数据分析员 临床协调员
职位描述
临床数据管理经理Clinical Data Manager
工作职责：
1. 在相关法律、法规和指导原则下进行数据管理工作，并负责整个过程的质量控制；
2. 参与临床研究方案设计，制定数据管理解决方案和进度计划；
3. 撰写和审阅数据管理的相关文件DMP/DVP等，负责及时更新和存档；
4. 管理数据管理系统供应商，确保供应商提供的服务和标准符合项目要求和相关法律规定；
5. 组织/实施/审核/批准CRF/EDC的设计，包括医学编码/系统的验证/用户接收测试（UAT）；
6. 监督全部数据活动，包括CRF表数据和外部电子化数据的录入、审核、验证和维护；
7. 监督数据的日常清理以及质疑表的管理（发送，追踪和关闭等）；
8. 在规定时间内完成一次性数据核查报告和进展报告，负责医学编码并根据需要完成质疑表；
9. 组织数据审核会议，准备数据审核会议所需资料；
10. 负责数据库锁定前的数据审核，如严重不良事件的一致性检查等；
11. 进行数据导出并产生研究数据集，供临床统计分析；
12. 完成部门的其他相关工作。
职位要求：
1. 本科及以上学历，医学、医学统计等相关专业；
2. 有制药企业或CRO公司相关工作经验，有肿瘤和免疫疾病临床数据管理工作经验者优先；
3. 了解ICH-GCP，了解药物研发全过程，熟悉临床试验全过程以及数据管理流程；
4. 有EDC的使用经验，熟练运用电脑办公软件，SAS、SPSS等统计软件进行数据统计分析；
5. 具备独立查阅文献和撰写的能力；
6. 具有较强的执行力，优秀的书面和语言表达能力，积极善于沟通，较强的适应能力和抗压能力；
7. 具有团队精神，良好的职业道德和奉献精神。
公司介绍
Andala Co. Ltd. is a well-known company with years of development in China. Its sales turnover and profit always rank at top in the Industry.
Guangzhou Andala Co. Ltd. aims at providing the efficient solution for supply chain with business in technology, FMCG, retailing, fashion, medicine, automotive, chemicals, aviation Industry and other industrial sectors. Headquarter of Guangzhou Andala Co. Ltd. locates in Guangzhou with branches in Shanghai and Beijing. The Company is trying to provide the most efficient one-stop service for the customers. We are committed to become a first-class multinational group.
Guangzhou Andala Co. Ltd. establishes a business network in many cities in China. With good reputation, Guangzhou Andala Co. Ltd. has been widely recognized and praised with its excellent service and continuously improved management systems. We will do all means to respect, take care of and motivate our staff to create an enjoyable environment.
As our business is expanding quickly now, we sincerely invite competent and self-motivated individuals to join our team. We offer attractive remuneration package and career development opportunities to successful candidates. Candidates please send your applications with detail resume both in Chinese and English, recent photo, expected salary and contact number to our designated email address: hrjob88@foxmail.com
有意者请将个人简历发至邮箱：hrjob88@foxmail.com,谢谢合作!应聘资料将予保密。
Guangzhou Andala Co. Ltd. aims at providing the efficient solution for supply chain with business in technology, FMCG, retailing, fashion, medicine, automotive, chemicals, aviation Industry and other industrial sectors. Headquarter of Guangzhou Andala Co. Ltd. locates in Guangzhou with branches in Shanghai and Beijing. The Company is trying to provide the most efficient one-stop service for the customers. We are committed to become a first-class multinational group.
Guangzhou Andala Co. Ltd. establishes a business network in many cities in China. With good reputation, Guangzhou Andala Co. Ltd. has been widely recognized and praised with its excellent service and continuously improved management systems. We will do all means to respect, take care of and motivate our staff to create an enjoyable environment.
As our business is expanding quickly now, we sincerely invite competent and self-motivated individuals to join our team. We offer attractive remuneration package and career development opportunities to successful candidates. Candidates please send your applications with detail resume both in Chinese and English, recent photo, expected salary and contact number to our designated email address: hrjob88@foxmail.com
有意者请将个人简历发至邮箱：hrjob88@foxmail.com,谢谢合作!应聘资料将予保密。
联系方式
- Email：hrjob88@foxmail.com
- 公司地址：地址：span松山湖