长沙招聘

职位描述：
1.岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
Responsible for trials, which requires technical specialization, the ability to interface with investigators/doctors;
Responsible for the drafting protocol and CT report;
Summarize and share with RA group the CT study experience.
2.主要职责 / MAIN ACCOUNTABILITIES
1）Ensure the implementation of project plans as assigned;
2）Responsible for plan and protocol writing, data controlling, data reporting, and final report writing;
3）Take part in site selection, site qualification, site monitoring, site management, site administration and registry management for clinical studies according to GCP, ICH Guidelines, and local regulations;
4）Prepare clinical trials, including ordering reagents, researching & writing trial plans and protocols, setting-up, equipping & training sites;
5）Make CT record and ensure the proper storage;
6）Take part in negotiating site contracts;
7）Conduct & monitor clinical trials and analyze data;
8）Problem solving & troubleshooting efforts on technical issues;
9）Prepare the final trial reports & close the trial;
10）Technical review to launch & close trials;
11）Collaborate with investigators on scientific posters & papers.
3.知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE
1.MSc in a scientific field (biology, pharmacy), medical background preferred
2.1-3 years’ clinical research experience in the relevant industry, IVD preferred
3.Good knowledge of clinical trial process
4.Good knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements, China regulation understanding preferred
5.Basic knowledge of protocol and other record drafting
6.Chinese native speaker with fluent English in both written and oral 举报 分享

      生物梅里埃公司创建于1963年，公司以来自身的科技创新和工业生产资源，始终致力于医疗和工业用途的体外诊断产品。生物梅里埃的诊断系统由试剂、仪器和软件组成，主要围绕感染性疾病、工业微生物、心血管病和肿瘤四个战略领域设计。生物梅里埃的使命是通过体外诊断，为全球公共卫生事业做出贡献。
      目前，生物梅里埃在全世界拥有19个工业生产工厂；20个研发基地；业务遍及世界六大洲160个国家，在44个国家和地区设有分支办事机构；全球雇员近13000人。凭借55年的经营，生物梅里埃如今在全球体外诊断行业扮演着重要的角色，在全世界诊断企业排名中位列前十，是临床微生物学和工业微生物学领域的翘楚。
      放眼未来，生物梅里埃将继续秉承传统、恪守承诺，全力为客户研发和提供***整体解决方案，力争成为推动全球公共卫生事业发展的领导者。