PRIMARY PURPOSE AND OVERALL IVE OF THE JOB:
1.Responsible for clinical trials, which requires technical specialization, the ability to interface with investigators/doctors
2.Summarize and share with RA group the CT study experience.

MAIN ACCOUNTABILITIES:
1.Ensure the implementation of project plans as assigned
2.Support clinical research manager in general study plan and protocol writing, data management and analysis, and final report writing
3.Support clinical research manager in study contract negotiation and signing, study problem solving and troubleshooting.
4.Take part in site ion and uation , site monitoring, site management, site close-out and registry management for clinical studies.
5.Manage study materials, including reagents ordering and storage, trial master file management, instrument setting-up, equipping & training sites
6.Ensure all clinical trials activities and documents are in compliance with local regulations, ICH GCP and company SOPs
7.Technical review to launch & close trials
8.Collaborate with investigators on scientific s & papers.

KNOWLEDGE, LANGUAGE AND EXPERIENCE:
1.MSc in a scientific field (biology, pharmacy), medical 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

生物梅里埃公司創建于1963年，公司依賴自身的科技研究和工業生產資源，始終致力于開發作為醫療和工業用途的體外診斷產品。 集團專門設計、開發、生產和推廣應用在臨床和工業的系統。生物梅里埃的診斷系統是由試劑、 儀器和軟件組成，主要是為傳染病、工業微生物控制、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。

生物梅里埃公司產品有兩個應用領域 : 臨床和工業，臨床市場占總銷售額的85.5%，而工業市場占14.5%。工業的應用主要在食品、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商。

生物梅里埃中國有限公司已經20年的發展，自動化微生物鑒定分析系統的用戶已達1400余家，自動微生物培養系統已達700余家，全自動細菌計數系統60余臺，手工產品用戶覆蓋全國的省市70%以上。同時公司擁有數十名微生物臨床及工業領域專業人員和工程技術人員，其中許多人員都來自檢驗一線，擁有豐富的檢驗經驗和儀器維修經驗。全面負責生物梅里埃公司產品的銷售，儀器的安裝、維護及保養，以及用戶的培訓及技術支持。