1.崗位設(shè)立的目的及目標(biāo) / 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(zé) / 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(yàn)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(tuán)專門設(shè)計(jì)、開發(fā)、生產(chǎn)和推廣應(yīng)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(gè)主要策略性領(lǐng)域來設(shè)計(jì)。

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

生物梅里埃公司產(chǎn)品有兩個(gè)應(yīng)用領(lǐng)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(yīng)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(lǐng)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(dá)1400余家，自動微生物培養(yǎng)系統(tǒng)已達(dá)700余家，全自動細(xì)菌計(jì)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(shí)公司擁有數(shù)十名微生物臨床及工業(yè)領(lǐng)域?qū)I(yè)人員和工程技術(shù)人員，其中許多人員都來自檢驗(yàn)一線，擁有豐富的檢驗(yàn)經(jīng)驗(yàn)和儀器維修經(jīng)驗(yàn)。全面負(fù)責(zé)生物梅里埃公司產(chǎn)品的銷售，儀器的安裝、維護(hù)及保養(yǎng)，以及用戶的培訓(xùn)及技術(shù)支持。