PM项目经理 北京

月薪： 60-80万/年

该公司所有职位
  • 无工作经验
  • 本科
  • 招若干人
  • 11-09 发布

职位描述

职位描述： 1.Prepare project management plans and templates to be used for the trial including but not limited to: Monitoring Plan, Trial Risk Management Plan (handled in CTMS), Communication Plan, Recruitment Plan, Definition of important milestones and key performance indicators (KPIs) for the trial etc.2.To be responsible for monitoring on status of clinical trial according to project management plan. Ensure the clinical trial be completed within time schedule and budget.3.To ensure all the related clinical research operations and procedures are in compliance with protocol, Ferring’s SOPs, ICH-GCP/Chinese GCP and applicable local regulations.4.To be responsible for using CTMS in clinical trial and ensure that information entered into CTMS is accurate and updated timely.5.As the Project Leader in Detailed Clinical Trial Plan, ensure that information entered into Planisware is accurate and updated timely.6.To ensure selected sites meet the Ferring’s requirements and qualified with CFDA.7.To be responsible for arranging and preparing Investigator Meeting.8.To be responsible for the co-ordination of IMP/NIMP with IMP department.9.Responsible for the review and implementation of the CRF/e-CRF according to the final protocol in co-operation with the data manager.10.To be responsible for public disclosure of clinical trial according to the Ferring’s SOPs and applicable local regulation.11.To ensure the study sites storage, distribution, return IMP/NIMP and report of deviations in compliance with protocol, Ferring’s SOPs, ICH-GCP/Chinese GCP and applicable local regulations.12.To ensure the study sites report appropriately all AEs according to timeline stipulated in clinical study protocols.13.To ensure the quality of the data.14.Conduct co-monitoring visits, if appropriate.15.To ensure transfer the trial related documents to CTA on time.16.To ensure the accuracy and completeness of Trial Master Files.17.To be responsible for working to coordinate for audits and take responsibility for the responses and corrective actions to audit finding.18.To ensure complete the Monthly Report on time and submit to Clinical Operation Manager. 职能类别： 生物工程/生物制药

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公司信息

广州澳佛莱人力资源服务有限公司（Synergy Consulting）是一家致力于全方位人力资源和管理咨询培训服务的专业机构。经过多年的努力和探索，我们不断地进步和成长。今天，我们拥有多样化的产品和优质的服务，我们拥有值得骄傲的团队和客户。 2010年 澳佛莱在广州成立 2011年 澳佛莱组建猎头部，为综合业务集团公司、制造业、物业地产、化工、医药、国际采购、零售、IT、电子等行业提供中高级人才访寻服务 2013年 澳佛莱上海办事处成立，为客户提供专业中高级人才访寻服务

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