职位类别： 生物/制药/医疗器械 医疗/护理/保健/美容 工作地点： 上海 发布日期： 2008-04-03 工作经验： 3-5年 最低学历： 本科 管理经验： 否 工作性质： 全职 招聘人数： 若干 职位描述/要求： Location : Guang zhou; Shang hai Main Tasks: Overseeing the management and administration of all aspects of clinical trials/studies involved in each step of the clinical trial/study. Assisting with preparation of protocols and other necessary documents required for trial approval by HA. Preparing protocols and other necessary documents required for trial approval by EC and getting EC approval on time. Monitoring and coordinating the clinical trial conduction in whole process by following GCP and SOP strictly. Make monitoring plan, co-monitoring plan, budget and tracking plan and followed it during trial process. Tracking progress, status and performance regularly, find current problems/issues and make appropriate action plans. Coordinating and giving input to all activities including query resolution, site closure and collection of documentation required for c li nical trial reports after trail end. Ensuring but not li mited to, IMPACT, EDC system for administration of clinical trials is updated in a timely and accurate manner in accordance with requirements. Ensuring all SAEs/adverse drug reactions are reported and followed up in a timely manner according to internal relevant SOP Maintaining, updating and archiving all c li nical trial files on time. Maintaining up to date knowledge of diabetes treatment, company products, and cli nical trial conduction. Being LTM for CDP trial when needed, keep close contact with IO CDC or HQ project team. Being project leader when needed, coordinate and lead team members have regular project review meeting, ensure accuracy of meeting minutes. Coaching CRA from technical point. Any other responsibi li ties and duties which may be required from time to time. Qualifications: Bachelor"s degree or above of Medical Science. Rich working experience in conducting clinical trials. Fluency English on both written&verbal. 联系方式： 北京建国门外大街1号 国贸大厦2座31层， 诺和诺德（中国）制药有限公司 人力资源部收 (请在信封及简历上注明应聘职位) 邮编：100004， 传真: 010-65056668， E-mail: recruit@novonordisk.com (不可带附件) 请注明您所要申请的职位名称。 请注明您的户口所在地。 请您在应聘材料上标明，此职位的信息来源于zhaopin.com. .
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