1.岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL IVE 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

1Ensure the implementation of project plans as assigned
2Responsible for plan and protocol writing, data controlling, data reporting, and final report writing
3Take part in site ion, site qualification, site monitoring, site management, site administration and registry management for clinical studies according to GCP, ICH Guidelines, and local regulations
4Prepare clinical trials, including ordering reagents, researching & writing trial plans and protocols, setting-up, equipping & training sites
5Make CT record and ensure the proper storage
6Take part in negotiating site contracts
7Conduct & monitor clinical trials and analyze data
8Problem solving & troubleshooting efforts on technical issues
9Prepare the final trial reports & close the trial
10Technical review to launch & close trials
11Collaborate with investigators on scientific s & papers.



3.知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE

1.MSc and above with major in Clinical Medicine
2.Basic knowledge of clinical trial process
3.Basic knowledge of GCP and ICH guidelines including understanding of regulatory requirements, China regulation understanding preferred
4.Basic knowledge of protocol and other record drafting
5.Chinese native speaker with fluent English in both written and oral

生物梅里埃公司创建于1963年，公司依赖自身的科技研究和工业生产资源，始终致力于开发作为医疗和工业用途的体外诊断产品。 集团专门设计、开发、生产和推广应用在临床和工业的系统。生物梅里埃的诊断系统是由试剂、 仪器和软件组成，主要是为传染病、工业微生物控制、心血管病和肿瘤病等四个主要策略性领域来设计。

在2008年，公司销售额为11亿1千1百万欧元，集团共有11个生产基地和9个研究中心，分布于欧洲、北美洲和南美洲。集团全球拥有38个办事处，至2008年12月31日集团员工超过5,700人。

生物梅里埃公司产品有两个应用领域 : 临床和工业，临床市场占总销售额的85.5%，而工业市场占14.5%。工业的应用主要在食品、药品和化妆品的微生物分析，增长非常迅速，生物梅里埃是全球体外诊断领域的第八大生产商。

生物梅里埃中国有限公司已经20年的发展，自动化微生物鉴定分析系统的用户已达1400余家，自动微生物培养系统已达700余家，全自动细菌计数系统60余台，手工产品用户覆盖全国的省市70%以上。同时公司拥有数十名微生物临床及工业领域专业人员和工程技术人员，其中许多人员都来自检验一线，拥有丰富的检验经验和仪器维修经验。全面负责生物梅里埃公司产品的销售，仪器的安装、维护及保养，以及用户的培训及技术支持。