Data Management Leader 上海

月薪： 1-2万/月

该公司所有职位
  • 2年经验
  • 本科
  • 招2人
  • 03-04 发布
  • 专业培训
  • 五险一金
  • 补充医疗保险
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 定期体检
  • 弹性工作
  • 年终奖金

职位描述

RequirementsResponsible for planning, execution, and delivery of Clinical Data Management projects on schedule and within budget, and within PPC and/or sponsor Standard Operating Procedures (SOPs).ResponsibilityCollaborate with respective project sponsor and stakeholders to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timing. Develop and implement project plans for relevant Data Management projects. Serve as Data Management Lead on selected projects Create project specific Data Management Plans (DMPs) Preparations of edit check specifications for a specific project, Data entry guidelines preparation, Case Report Form design and associated specification under the support of CDAs. Assist with and/or oversee the creation of test data for entry screens and edit checks Serve as primary contact for DM with all relevant parties including but not limited to Clinical Operations and Sponsor, informing stakeholders if there is a need to deviate from project scope or plan Participate/attend Sponsor requested meetings as required Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections Perform other duties as required by the Department. qualifications and experienceBSc degree in biological science or a related discipline in the science/healthcare field or equivalent education Minimum 3 years of experience including proven ability to lead data management activitiesEffective communication skills Ability to drive and oversee a cross-functional team via effective delegation and team workload assignment 职能类别： 临床数据分析员 关键字： DM Data Management 临床数据管理

联系方式

黄陂南路（地址1号线新天地站，9、10、13号线马当路站）

公司信息

PPC佳生（Protech PharmaservicesCorporation）成立于1997年，致力于为国内外制药企业及生物技术公司提供专业化临床研究服务，为中国大陆、中国台湾、韩国以及日本等亚太地区客户提供临床试验及生物样本检测分析服务。自1997年至今，自成立以来，PPC佳生已为来自全球范围客户完成了2000多个早期临床研究项目（包含新药I期PK、仿制药BA/BE以及生物类似药PK/PD）；并且还执行了超过400个新药后期临床试验项目；所执行的研究方案涵盖24个疾病治疗领域。目前是亚太区域唯一通过日本PMDA、欧盟ANSM、东盟NCPB以及美国FDA核查的临床基地，生物样品实验室开发约300种药品分析方法，以丰富的执行经验提供海内外客户优质服务。2012年，PPC佳生于台北（McKay memorial Hospital）建立了第一家下属I期临床试验中心，并于2016年作为主要投资方与徐州医科大学资源共享，优势互补联合组建合作共同建立了徐州医科大学附属医院I期药物临床试验中心。

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