北京招聘

职位描述：
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, SSD, PM, DMS) 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.

 

任职要求：Above 2 years Data Management experience. 举报 分享

精鼎医药（Parexel International）是全球领先的药物研究合同委托机构（CRO），总部位于美国生物医药圣地马萨诸塞州的波士顿附近，在世界各地拥有71个办事处，约17,600 名员工，为超过100个国家的客户提供服务。

精鼎医药成立于1982年，在三十多年的历程中，一直致力于发展成为全球生物制药和医疗器械行业首屈一指的新型医学疗法开发和商业化服务供应商，并且取得了卓越成果。目前，我们能够提供全世界CRO领域全面的新药临床阶段研发服务，服务内容包括新药开发策略的拟定与计划、国际临床试验规划执行及整合、临床试验的监测、临床试验数据处理、临床研究统计分析、临床试验总结及统计报告、临床试验稽核服务、临床试验供应和物流服务、临床电子数据采集、临床医学信息管理系统、新药查验登记事务和国际临床试验相关法规咨询等。

将我们的全球法规监管专业经验、I-IV期临床研究服务、整合的电子化临床技术能力和商业化服务结合在一起的一体化解决方案，可帮助我们的客户更加顺畅、经济和高效的推动整个研发历程。