職位描述
PRIMARY PURPOSE AND OVERALL IVE OF THE JOB:
1.Responsible for trials with protocols and CT report, which require technical specialization, requires the ability to interface with investigators/doctors
2.Responsible for the conducting clinical trial, which require clearance of the CT process
3.Provide guidance & advice to more junior level CRAs & Project Teams
4.Assist department to set up CT strategy and overall control CT timeline
5.Assist department to build SOPs relate with CT.
MAIN ACCOUNTABILITIES:
1.Establish project plan with clear timeline and deliverables and ensure the implementation of the defined plan
2.Responsible for plan and protocol writing, data controlling, data reporting, and final report writing and guiding junior CRAs
3.Responsible for site ion, site qualification, site monitoring, site management, if necessary negotiate site contracts
4.Responsible for CROs ion as required
5.Coordinate complex studies at multiple sites potentially involving teams of CRA(Clinical Research Associate)
6.Prepare, conduct & monitor clinical trials, coordinate all contact with the sites, problem solving, analyzing data lead problem solving & troubleshooting on technical issues
7.Lead reviews of data periodically & keep Project Team informed
8.Lead preparation of final trial reports & close the trial.
KNOWLEDGE, LANGUAGE AND EXPERIENCE:
1.MSc in a scientific field (biology, pharmacy), Medical preferred
2.3-5 years’ clinical research experience in the relevant industry, IVD industry with team management experience preferred
3.Good knowledge of clinical trial process and the process of sites
4.Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements, Chinese regulation preferred
5.Chinese native speaker with fluent English in both written and oral
企業(yè)介紹
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(dòng)化微生物鑒定分析系統(tǒng)的用戶已達(dá)1400余家，自動(dòng)微生物培養(yǎng)系統(tǒng)已達(dá)700余家，全自動(dòng)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。
