20-30万
临床数据经理
xx科技开发有限公司
北京 6年 本科以上 2018.10.17

职位描述

基本信息:
所属行业:
制药/生物工程
所属部门:
数据中心
汇报对象:
数据中心总监
工作地点:
北京
职位编号:
34137
1. Responsible for data management 
1.1.Reviews and understands study protocol and assures consistency internal to the protocol and the goals of the study.
1.2.Designs Case Report Forms (CRF) and coordinates review by project team
1.3.Review DMP, and DVP, and DMR,etc. 
1.4.Review of clinical trial data, identifies erroneous, missing, incomplete, or implausible data and review DCF.
1.5.Understands the fundamental needs for and uses of relational databases and can work with database programmers to ensure proper clinical database design.
1.6.Review the coding of CM and AE. 
1.7.Ensures that all external data is imported into the database and define quality acceptance criteria for electronic data .
1.8.Assigns tasks to project team. 
2. Responsible for project management
2.1.Coordinates with Project Coordinator to assure timely of project progress.
2.2.Represents Data Management at project team meetings and provides updates to project team on status of DM tasks
2.3.Ensures that all preparatory steps to lock a clinical database are accomplished and database is locked successfully and within the timelines
2.4.Ensures adherence to all timelines associated with data management
2.5.Assures that the data management needs of project(s) are met, reporting all areas of concern to the Manager of DM Department to assure timely and appropriate resolution of client issues
2.6.Assures that all aspects of data management are performed in accordance with client requirements and applicable corporate SOPs, Guidelines and ICH standards, as appropriate
3. Responsible for team management 
3.1.Responsible for team development, put forward opinions and suggestions of the personnel assignment, training and evaluation.
3.2.Responsible for the coordination of staffs and departments.
3.3.Responsible for organizing the internal training.
3.4.Responsible for formulating training plan for new stuffs.
4. Complete other tasks assigned by the department manager or company.

MINIMUM REQUIREMENTS:
1.Bachelor’s degree or above in medical or healthcare-related science.
2.Minimum three years of clinical data management experience in a pharmaceutical company or CRO.
3.Demonstrated strong skills in the management and resolution of data-related issues
4.Exhibits increased understanding of relational databases and their functionalities
5.Strong communication and analytical skills
6.Demonstrated organizational skill and ability to prioritize multiple tasks
7.Be able to manage multiple projects, as necessary
8.Strong team-building skills and the ability to work successfully in a team environment
9.Knowledgeable about GCP and ICH requirements
10.Demonstrated verbal and written communication skills in both Chinese and English. 
11.Demonstrated computer skills including

职位要求

学历要求:
本科以上
性别要求:
不限
语言要求:
不限
年龄要求:
30岁-35岁
工作年限:
6年

企业介绍

由成立于 2003年的迪美斯,成立于2004年的医协众泰和成立于2009年的博尔泰科三家公司整合成立于2010年9月。原三家公司分别在CRO、医疗器械报批及注册及SMO方面独具特色,并在行业内享有盛誉。基于各自深厚的专业功底、广泛的资源优势,强大敬业的专业团队及对行业的深刻认识和独到见解,普瑞盛将继续秉承“以真诚与务实为客户创造价值”的服务理念,致力于打造卓越的国际化公司。
展开信息

猎头信息

Summer
Summer
行业:IT/通讯/互联网
职位:185
  • 立水桥公司
  • 13651092975
  • 839886918@qq.com

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