行业:医药生物|医疗保健
职位:医药/生物工程
部门:
人数:若干
地区:北京
性质:全职
性别:不限
婚姻:不限
学历:本科
经验:不限
年龄:不限年龄
待遇:面议
500强 英语环境 全市班车 免费午餐
Primary Purpose of Job (Job Summary) 主要工作目标（岗位简介）Scanning Hub Support• Reviewand scan the clinical trial related documents with high quality according tothe scanning hub requirements and upload to required system within requiredtimeline.• Maintainlocal scanning hub public mailbox in a timely manner including review, replyand archive important communication.• Maintainthe local scanning status tracker daily to ensure all documents could bescanned and uploaded within required timeline.• Answerand resolve any query from global scanning hub responsible, CDC.• Providesupport and input to improve the local process of scanning if needed. Clinical Trial document Archiving • Befamiliar with the content of clinical trial master file and investigator sitefile based on the requirements of ICH GCP, China regulation and Roche SOPs,guidance.• Reviewthe closed clinical trial documents, support archiving responsible to arrangeand archive them according to related SOP requirements. Business Support to Department• UnderstandICH GCP, China GCP and related regulation on clinical trials, especially onEthic Committee (EC) requirements for study initiation.• SupportSSUS to prepare the essential EC submission package according to requiredtimeline. General Office Duties• Providegeneral office support to PDG CCO department staff (including but not limitedto photocopying, distributing mail/faxes, scanning, faxing,).• Organizecourier services for documents/ goods pick-up.Administrative supports on the activitiesassigned by line manager
Qualification and Experience 能力与经验Education/Qualifications教育程度/所获资格证书Bachelor degree preferred (4th  year student)Major in Pharmacy or medical related Personality岗位性格胜任能力§ Good ownership and focus on details§ Logical and efficient with highly compliance§ Be willing to learn, think and practice JobRequired Competencies岗位所需胜任力§  Good Computer skill for Window 7, Microsoft 2010 (PPT,Excel, Word)§  Strong communication skills§  Fluent English written and oral capability