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
企業介紹
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。
