1.崗位設立的目的及目標 / 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.主要職責 / 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.知識、語言和經(jīng)驗要求 / 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

生物梅里埃公司創(chuàng)建于1963年，公司依賴自身的科技研究和工業(yè)生產(chǎn)資源，始終致力于開發(fā)作為醫(yī)療和工業(yè)用途的體外診斷產(chǎn)品。 集團專門設計、開發(fā)、生產(chǎn)和推廣應用在臨床和工業(yè)的系統(tǒng)。生物梅里埃的診斷系統(tǒng)是由試劑、 儀器和軟件組成，主要是為傳染病、工業(yè)微生物控制、心血管病和腫瘤病等四個主要策略性領域來設計。

在2008年，公司銷售額為11億1千1百萬歐元，集團共有11個生產(chǎn)基地和9個研究中心，分布于歐洲、北美洲和南美洲。集團全球擁有38個辦事處，至2008年12月31日集團員工超過5,700人。

生物梅里埃公司產(chǎn)品有兩個應用領域 : 臨床和工業(yè)，臨床市場占總銷售額的85.5%，而工業(yè)市場占14.5%。工業(yè)的應用主要在食品、藥品和化妝品的微生物分析，增長非常迅速，生物梅里埃是全球體外診斷領域的第八大生產(chǎn)商。

生物梅里埃中國有限公司已經(jīng)20年的發(fā)展，自動化微生物鑒定分析系統(tǒng)的用戶已達1400余家，自動微生物培養(yǎng)系統(tǒng)已達700余家，全自動細菌計數(shù)系統(tǒng)60余臺，手工產(chǎn)品用戶覆蓋全國的省市70%以上。同時公司擁有數(shù)十名微生物臨床及工業(yè)領域?qū)I(yè)人員和工程技術人員，其中許多人員都來自檢驗一線，擁有豐富的檢驗經(jīng)驗和儀器維修經(jīng)驗。全面負責生物梅里埃公司產(chǎn)品的銷售，儀器的安裝、維護及保養(yǎng)，以及用戶的培訓及技術支持。