Senior Data Management(Study Data Management)
赛诺菲(中国)投资有限公司上海分公司
- 公司规模:5000-10000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2015-02-13
- 工作地点:北京
- 招聘人数:1
- 学历要求:本科
- 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
RANK MAJOR DUTIES & RESPONSIBILITIES (what the job does) END RESULTS EXPECTED
(why is it done/impact)
1. Primary contact between CDM and clinical study teams. Liaises directly with internal customers (Clinical, Biostatistics, Quality Assurance, Regulatory Affairs) and external customers (affiliates, CROs, clinical research units) to cover all aspects of data management for assigned studies. Negotiates responsibilities and timelines. Ensures departmental companion groups (i.e., Coding, CRF design, DSD) are consulted appropriately on study decisions. Implements and oversees processes and coordinates activities in conjunction with the study team and Project Leader. Proposes solutions for data management issues that arise during the conduct of a study
Clear and effective Data Management Plan for each study. High quality Database locked per timelines. Interim deliverables, such as interim analyses databases, delivered according to team specifications and timelines.
2. In charge of the development of protocols, CRFs, Data Management Plan, Data Validation Plan, Data Review Report as per company standards. Assures that data management standards are followed for the studies in charge. High quality CRFs, Data Management Plan, including Data Validation Plan, and Data Review Report.
3. Coordinates CDM study teams (Clinical Data Coordinators, contractors) assigned to support studies. Effective leadership of CDM study team. Clear assignment of individual tasks and adequate use tracking tools to monitor study progress.
4. Continually evaluates CDM processes and applications for improvements. Participates in working groups to develop and implement new applications and procedures. Maintains knowledge of current regulations and technologies related to the data management function. Deputizes for the Project Leader Data Management, when appropriate. Participates in the implementation of department initiatives. Best practices applied to all aspects of CDM project/study activities.
Formal Education And/Or Experience Required:
Bachelor degree or above, preferably in a life science or mathematics-related area (e.g., computer sciencecs) or equivalent experience (at least 3 years) in clinical data management.
Oral and written English communication skills.
(why is it done/impact)
1. Primary contact between CDM and clinical study teams. Liaises directly with internal customers (Clinical, Biostatistics, Quality Assurance, Regulatory Affairs) and external customers (affiliates, CROs, clinical research units) to cover all aspects of data management for assigned studies. Negotiates responsibilities and timelines. Ensures departmental companion groups (i.e., Coding, CRF design, DSD) are consulted appropriately on study decisions. Implements and oversees processes and coordinates activities in conjunction with the study team and Project Leader. Proposes solutions for data management issues that arise during the conduct of a study
Clear and effective Data Management Plan for each study. High quality Database locked per timelines. Interim deliverables, such as interim analyses databases, delivered according to team specifications and timelines.
2. In charge of the development of protocols, CRFs, Data Management Plan, Data Validation Plan, Data Review Report as per company standards. Assures that data management standards are followed for the studies in charge. High quality CRFs, Data Management Plan, including Data Validation Plan, and Data Review Report.
3. Coordinates CDM study teams (Clinical Data Coordinators, contractors) assigned to support studies. Effective leadership of CDM study team. Clear assignment of individual tasks and adequate use tracking tools to monitor study progress.
4. Continually evaluates CDM processes and applications for improvements. Participates in working groups to develop and implement new applications and procedures. Maintains knowledge of current regulations and technologies related to the data management function. Deputizes for the Project Leader Data Management, when appropriate. Participates in the implementation of department initiatives. Best practices applied to all aspects of CDM project/study activities.
Formal Education And/Or Experience Required:
Bachelor degree or above, preferably in a life science or mathematics-related area (e.g., computer sciencecs) or equivalent experience (at least 3 years) in clinical data management.
Oral and written English communication skills.
公司介绍
赛诺菲集团
赛诺菲集团是一家全球领先的多元化医药健康企业,专注于患者需求,传播健康。
- 全球100,000余名员工,业务遍及100个国家
- 新兴市场实力均衡,表现强劲,位列***
- 多元领域,覆盖处方药、健康药业产品、疫苗和动物保健品
- 疫苗领域的领导者
- 领先动物保健市场
- 2011年集团净销售额达334亿欧元
赛诺菲在中国
赛诺菲是首批在中国开设办事处的跨国制药集团,也是国内增长最快的医药健康企业之一。目前,赛诺菲在中国200多个城市拥有6000余名员工。
传承悠久历史、持续开拓进取
赛诺菲一直以来秉承对中国的承诺。1982年,赛诺菲成为首批在中国开设办事处的跨国制药企业之一。今天,赛诺菲已跻身中国医药健康市场的领军企业。赛诺菲的中国总部位于上海,并在北京、天津、沈阳、济南、上海、杭州、南京、武汉、成都、广州和乌鲁木齐共设11家区域办公室。
独特的医药健康产品系列、满足中国公共卫生需求
从预防到治疗,赛诺菲全方位满足中国的公共健康需求。集团的疫苗事业部赛诺菲巴斯德是中国领先的疫苗企业。赛诺菲在心血管/血栓、糖尿病、肿瘤、内科和中枢神经系统等关键的治疗领域拥有领先产品。2010年,杭州赛诺菲民生健康药业有限公司的成立标志着赛诺菲进入中国的非处方药市场。2011年2月,赛诺菲完成了对BMP太阳石的收购。
大幅投资工业建设、满足中国市场需求
赛诺菲目前在中国拥有六家生产基地,包括北京制药工厂、杭州制药工厂、杭州赛诺菲民生健康药业工厂、南昌梅里亚动物保健工厂、深圳赛诺菲巴斯德疫苗工厂、以及唐山健康药业工厂。
完善的研发架构、双赢的研发合作模式
在中国,赛诺菲具有从药物靶点发现到后期临床研究的整体研发实力。集团在上海设有中国研发中心和亚太研发中心,并在北京和成都分别设有研发机构。自2008年以来,赛诺菲与中国权威科研机构开展了10多项战略合作,在癌症、干细胞、糖尿病和老年疾病等前沿研究领域探索创新药物
依托于强劲的研发能力和多领域领先水平的广泛的医药产品资源,公司在中国的市场份额不断攀升,公司规模不断扩大,飞速发展的业务给了我们与更多优秀人才合作的机会。
如需了解更多信息,请访问*************
现在就行动!把握机遇,加入我们,您的职业生涯将与赛诺菲共同成长!抓住机会,来亲身体验我们所秉持的胆略、创新、团结、勇气的价值观。
请将您的中英文简历发给我们,并在email标题栏注明您所申请的职位名称。每个职位申请一次即可,请不要重复投递简历。谢谢!
赛诺菲集团是一家全球领先的多元化医药健康企业,专注于患者需求,传播健康。
- 全球100,000余名员工,业务遍及100个国家
- 新兴市场实力均衡,表现强劲,位列***
- 多元领域,覆盖处方药、健康药业产品、疫苗和动物保健品
- 疫苗领域的领导者
- 领先动物保健市场
- 2011年集团净销售额达334亿欧元
赛诺菲在中国
赛诺菲是首批在中国开设办事处的跨国制药集团,也是国内增长最快的医药健康企业之一。目前,赛诺菲在中国200多个城市拥有6000余名员工。
传承悠久历史、持续开拓进取
赛诺菲一直以来秉承对中国的承诺。1982年,赛诺菲成为首批在中国开设办事处的跨国制药企业之一。今天,赛诺菲已跻身中国医药健康市场的领军企业。赛诺菲的中国总部位于上海,并在北京、天津、沈阳、济南、上海、杭州、南京、武汉、成都、广州和乌鲁木齐共设11家区域办公室。
独特的医药健康产品系列、满足中国公共卫生需求
从预防到治疗,赛诺菲全方位满足中国的公共健康需求。集团的疫苗事业部赛诺菲巴斯德是中国领先的疫苗企业。赛诺菲在心血管/血栓、糖尿病、肿瘤、内科和中枢神经系统等关键的治疗领域拥有领先产品。2010年,杭州赛诺菲民生健康药业有限公司的成立标志着赛诺菲进入中国的非处方药市场。2011年2月,赛诺菲完成了对BMP太阳石的收购。
大幅投资工业建设、满足中国市场需求
赛诺菲目前在中国拥有六家生产基地,包括北京制药工厂、杭州制药工厂、杭州赛诺菲民生健康药业工厂、南昌梅里亚动物保健工厂、深圳赛诺菲巴斯德疫苗工厂、以及唐山健康药业工厂。
完善的研发架构、双赢的研发合作模式
在中国,赛诺菲具有从药物靶点发现到后期临床研究的整体研发实力。集团在上海设有中国研发中心和亚太研发中心,并在北京和成都分别设有研发机构。自2008年以来,赛诺菲与中国权威科研机构开展了10多项战略合作,在癌症、干细胞、糖尿病和老年疾病等前沿研究领域探索创新药物
依托于强劲的研发能力和多领域领先水平的广泛的医药产品资源,公司在中国的市场份额不断攀升,公司规模不断扩大,飞速发展的业务给了我们与更多优秀人才合作的机会。
如需了解更多信息,请访问*************
现在就行动!把握机遇,加入我们,您的职业生涯将与赛诺菲共同成长!抓住机会,来亲身体验我们所秉持的胆略、创新、团结、勇气的价值观。
请将您的中英文简历发给我们,并在email标题栏注明您所申请的职位名称。每个职位申请一次即可,请不要重复投递简历。谢谢!
联系方式
- Email:recruit.westchina@sanofi-aventis.com
- 公司地址:上海市 静安区延安中路1228号 静安嘉里中心办公楼3座19楼 (邮编:200040)