诺和诺德（中国）制药有限公司

职位：Sr.CRA
发布时间：2007-04-23
工作地点：上海
信息来源：前程无忧
职位类型：全职
职位描述
诺和诺德（中国）制药有限公司

医学部

Sr.CRA

电子邮箱： " target="_blank">recruit@

发布日期： 2007-04-23 工作地点： 上海市

招聘人数： 若干

外语要求： 英语 熟练 薪水范围： 面议

学 历： 本科

职位描述：
Area of responsibilities:
Main Tasks:
Duties and responsibilities which are subject to periodic updating include:
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 clinical trial reports after trail end.
Ensuring but not limited 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 clinical trial files on time.
Maintaining up to date knowledge of diabetes treatment, company products, and clinical 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 responsibilities and duties which may be required from time to time.

Supervision:
None

Main customers:
Internal customers:

All the internal colleagues in CRO, especially MED, MKT & Sales colleagues. The clinical operation colleagues in headquarters, IOCDC & other affiliates.
External customers:
All the healthcare professionals, officials. Especially the investigators in the clinical trials.

Education and Experience Requirements of the Position:
1.Bachelor's degree or above of Medical Science.
2.Rich working experience in conducting clinical trials.
3.Fluency English on both written & verbal.

公司简介

诺和诺德是世界领先的生物制药公司，在用于糖尿病治疗的胰岛素开发和生产方面居世界领先地位。诺和诺德总部位于丹麦首都哥本哈根，员工总数21,000人，分布于70个国家，产品销售遍布179个国家。在欧美均建有生产厂。
诺和诺德的产品60年代初就已进入中国市场。1994年初，诺和诺德董事会通过了在中国实施战略投资的计划，在北京建立诺和诺德（中国）制药有限公司总部和生物技术研究发展中心，在天津兴建现代化生产工厂，并在全国30多个城市建立了完善的营销体系。欲了解详情，请访问诺和诺德中国网站：ww***com[点击查看]

为配合公司在中国业务的迅速发展，现诚聘。

诺和诺德将为您提供具有竞争力的薪酬及福利、完善的个人发展与培训机会，使您在国际化的管理与富有挑战性的工作环境中不断地进步与自我实现！应聘者请将个人简历、期望薪水、身份证、学历证明复印件于10日内寄至本公司。
请在信封上注明应聘职位。

公司网站： ww***com[点击查看]

地 址： 北京建国门外大街1号国贸大厦2座31层

邮政编码： 100004

传 真： (010)65056668

电子邮箱： " target="_blank">recruit@