数据管理经理 (DM Manager)
诺思格(北京)医药科技股份有限公司
- 公司规模:1000-5000人
- 公司性质:合资
- 公司行业:制药/生物工程
职位信息
- 发布日期:2022-06-25
- 工作地点:武汉-武昌区
- 工作经验:5-7年经验
- 学历要求:本科
- 语言要求:英语熟练
- 职位月薪:1.5-2.5万
- 职位类别:临床数据分析员
职位描述
1) Develop and manage development of the specification documents in DM processes
2) Lead the development of the data management plans (DMP).
3) Manage comprehensive data management tasks pertaining to the Data Management Plan.
4) Efficiently leads and oversights multiple projects in various stages simultaneously.
5) Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally.
6) Ability to work in ambiguous situations within teams to identify and articulate complex problems
7) Coordinate experiences sharing across studies, e.g. best practices, lessons learnt, metrics of trends analysis, etc.
8) Mentor other team members in training and developing data management expertise.
9) Independently bring project solutions to the data management team.
10) Interface with the client, sites and monitors as needed to manage the data collection and cleaning.
11) Oversee medical dictionary coding of adverse events and concomitant medications.
12) Manage the database lock process.
13) Supervise junior level data manager as needed (for senior level data manager).
14) Support BD groups in technical aspect as needed.
MINIMUM REQUIREMENTS
1) Bachelor degree or equivalent in medical science or related discipline.
2) Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design
3) 5+ years of previous experience within a data management role, working experience in clinical trials.
4) Advanced knowledge of the data management process / systems and experience in specialized data management skills.
5) Comprehensive understanding of clinical drug development process (detail oriented).
6) Familiar with ICH-GCP.
7) Capability to communicate effectively in English, both verbally and written.
8) Strong communication and coordinate skills, work as a team player.
公司介绍
“服务医药 服务健康”,详情请登录公司主页: *****************
接收简历邮箱:hr@rg-pharma.com(邮件主题:城市+岗位名称+本人姓名)
【子公司】苏州海科医药技术有限公司为诺思格(北京)医药科技股份有限公司的子公司,子公司成立于2015年01月14日,地址位于苏州工业园区裕新路108号4楼,经营范围包括生物技术开发、生物检测技术服务、会务服务,详情请登录公司主页:*******************************/
【子公司】南京艾科曼信息技术有限公司,专攻于临床研究领域中的数据管理和统计分析环节,全面移植美国CRO的质量标准及管理体系,一步到位与国际CRO行业接轨。同时,服务质量获得欧美主要药厂的认证。自成立以来已完成300余项临床项目,其中部分已经获得美国FDA及欧洲EMEA通过。率先使用国际标准数据管理系统,所有高管均有在美国相关行业从业10年以上经验。总部位于北京,在上海、南京、成都、武汉、合肥等省会设有办公室。
联系方式
- Email:hr@rg-pharma.com
- 公司地址:北京海淀区车公庄西路 19 号华 通大厦 B 座北塔 (邮编:100048)