数据管理专员
宁波瑞达医药科技有限公司
- 公司规模：少于50人
- 公司性质：民营公司
- 公司行业：制药/生物工程 外包服务
职位信息
- 发布日期：2014-05-30
- 工作地点：宁波
- 招聘人数：若干
- 学历要求：硕士
- 语言要求：英语精通
- 职位月薪：面议
- 职位类别：临床数据分析员
职位描述
Responsibilities:
1 Perform all data management activities to ensure the data accuracy and integrity.
2 Manage the progress of the project and prioritizes with respect to pre-determined timelines.
3 Work with project teams to ensure smooth transmissions of data.
4 The detail data management activities include but not limit to
Design Data Management Plan and report the data progress periodically.
Database design, CRF design and annotation.
CRF review, data entry guidelines and CRF completion guidelines.
Data Validation Plan development, data validation checks programming and query management.
SAS programming of listings.
Generation and tracking of data clarifications form.
database quality control.
Blind data review and database lock.
File archiving for all of the data management documents.
All other duties as assigned.
Qualifications:
1.Bachelor or above degree in medical, public health, pharmacology, or other related fields.
2.Two years of industry experience in clinical data management will be preferred.
3.Vast knowledge of all stages of data management
4.Knowledge of ICH GCP and China GCP
5.Familiar with sql and SAS programming
6.Fluent in English
7.Excellent computer skills
8.Willingness and capability to take initiative and help Clinical Research Associates and Statisticians resolve problems
9.Be able to work independently and complete a high volume of work
Best to obey the work location adjustment.
1 Perform all data management activities to ensure the data accuracy and integrity.
2 Manage the progress of the project and prioritizes with respect to pre-determined timelines.
3 Work with project teams to ensure smooth transmissions of data.
4 The detail data management activities include but not limit to
Design Data Management Plan and report the data progress periodically.
Database design, CRF design and annotation.
CRF review, data entry guidelines and CRF completion guidelines.
Data Validation Plan development, data validation checks programming and query management.
SAS programming of listings.
Generation and tracking of data clarifications form.
database quality control.
Blind data review and database lock.
File archiving for all of the data management documents.
All other duties as assigned.
Qualifications:
1.Bachelor or above degree in medical, public health, pharmacology, or other related fields.
2.Two years of industry experience in clinical data management will be preferred.
3.Vast knowledge of all stages of data management
4.Knowledge of ICH GCP and China GCP
5.Familiar with sql and SAS programming
6.Fluent in English
7.Excellent computer skills
8.Willingness and capability to take initiative and help Clinical Research Associates and Statisticians resolve problems
9.Be able to work independently and complete a high volume of work
Best to obey the work location adjustment.
公司介绍
瑞达是中国临床研究电子化的先锋和一家能为临床研究提供创新服务的CRO。瑞达推出了一款完全符合21 CFR Part 11，GCP和行业法规要求的高性价比系统– eRDDM。
瑞达医药科技有限公司创立于2008年，在中国北京、广州、成都、武汉、宁波、昆山、嘉兴和美国新泽西都设有分支机构。目前全世界卫生保健和医药研究领域正在发生翻天覆地的变化， 这些变化将从根本上对改变新药研发方向和模式产生永久性的影响。新药研发所需费用越来越昂贵，加上地域的分离以及公共卫生资源分布不平衡等因素， 严重制约了新药研发的速度和效率，如何寻找方法突破这些瓶颈和探索新的新药研发途径很有必要。IT和医药行业的技术创新和发展日新月异， 我们将利用这些现代化的技术和工具锐意为来自世界各国的医药，生物科技，医疗器械和合同研究公司提供优质价廉的服务。
我们致力于不断优化我们拥有完全知识产权的EDC/DM/CTMS/IWRS系统- eRDDM，为行业提供能够完全符合法规和GCP要求的临床研究纸张和电子数据处理系统；为 临床研究数据管理，质量控制，项目管理，网上监查和随机化等提供现代化工具；大力推广电子临床研究的模式，为提高临床研究水平和效率做贡献。
瑞达医药科技有限公司创立于2008年，在中国北京、广州、成都、武汉、宁波、昆山、嘉兴和美国新泽西都设有分支机构。目前全世界卫生保健和医药研究领域正在发生翻天覆地的变化， 这些变化将从根本上对改变新药研发方向和模式产生永久性的影响。新药研发所需费用越来越昂贵，加上地域的分离以及公共卫生资源分布不平衡等因素， 严重制约了新药研发的速度和效率，如何寻找方法突破这些瓶颈和探索新的新药研发途径很有必要。IT和医药行业的技术创新和发展日新月异， 我们将利用这些现代化的技术和工具锐意为来自世界各国的医药，生物科技，医疗器械和合同研究公司提供优质价廉的服务。
我们致力于不断优化我们拥有完全知识产权的EDC/DM/CTMS/IWRS系统- eRDDM，为行业提供能够完全符合法规和GCP要求的临床研究纸张和电子数据处理系统；为 临床研究数据管理，质量控制，项目管理，网上监查和随机化等提供现代化工具；大力推广电子临床研究的模式，为提高临床研究水平和效率做贡献。