• 3-4年经验
  • 本科
  • 招1人
  • 12-23 发布
  • 五险一金
  • 免费班车
  • 绩效奖金
  • 通讯补贴
  • 定期体检
  • 员工旅游
  • 年终奖金

职位描述

临床质量管理主管/Clinical QA Supervisor工作职责:1、根据临床试验方案制定项目稽查计划,并按照稽查计划对临床试验项目进行稽查,保证临床试验操作、报告及记录与试验方案、公司SOP、GCP以及相关的法规要求相符;2、负责完成稽查报告,提交部门总监审核;3、负责对临床研究项目稽查结果的后续追踪,督促稽查出的问题能得到及时的修改,收集项目稽查整改结果的反馈;4、负责管理部门临床试验管理体系文件,定期对部门文件进行审核,并组织部门人员对SOP进行撰写或更新;5、跟踪CFDA颁布的相关法规及指导原则,及时更新和撰写相关SOP文件;6、负责组织部门人员进行SOP培训,定期审核部门人员的培训记录,年终归档;7、负责部门临床试验项目的质量控制;8、协助制定月度、年度稽查计划。职位要求:1、临床医学、药学或相关专业,本科以上学历;2、5年以上监查工作经验;3、熟悉药物临床研究的有关法律法规;4、在合资或外资CRO或药企有过临床QA相关经验的,优先考虑;5、责任心强,具备较高的逻辑思维能力、执行能力、创新能力和协调沟通能力。 职能类别: 临床研究员 临床协调员 关键字: 临床质量管理 临床质量主管 临床质量专员 Clinical 临床试验 临床试验管理 临床QA

联系方式

广州市

公司信息

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: hrjob@foxmail.com 有意者请将个人简历发至邮箱:hrjob@foxmail.com,谢谢合作!应聘资料将予保密。

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