• 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 专业培训
  • 出国机会
  • 年终奖金

职位描述

职位描述: 职位职责Responsibilities:1、管理和协调跨职能项目团队的工作,并支持里程碑事件的完成,并处理临床试验出现问题和障碍,确保试验工具和培训材料的持续使用,并遵守标准流程、法律法规和程序。2、制定试验管理计划,与团队成员相互协作、恪守职责,并对试验产生数据持续进行监督。3、作为主要的项目联系人与研究者进行有效的沟通,以确保信息通畅,并遵守试验报告节点。4、通过有效沟通,研究者期望及反馈,与项目基线情况比较去进行团队成员绩效评估。5、领导问题的解决及努力去解决潜在的问题,包括风险管理、突发事件和问题。6、识别试验中的质量风险,采取适当的纠正计划。将发现的问题及对有关各方采取行动去解决。7、为试验的进一步发展提供可操作的建议,并在预算内管理试验项目。8、提供项目团队成员切实可靠的绩效表现数据,与应考核的项目任务匹配。9、在内部和外部会议中准备和呈递有关项目的信息。10、在分管领导的指导和监督下,参与公司项目方案设计与开发。11、通过有计划的协同监查、中心协访、参观与持续的对监查员团队进行培训,确保团队成员绩效表现和效率输出持续、稳定及高效。1.Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.2.Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.3.Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.4.Collect information on team performance against contract, customer expectations, and project baselines.5.Lead problem solving and resolution efforts to include management of risk, contingencies and issues.6.Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.7.Provide input for the development of proposals for new work and manage project budgets.8.Provide input to program director of their project team members performance relative to project tasks.9.Prepare and present project information at internal and external meetings.10.Participate in proposal development and in the bid-defense process with guidance and supervision.11.Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team.所需知识、技能和能力Required knowledge, skills and abilities: 1、具备一定程度的知识、应用型技能,适用于临床试验监管要求;例如GCP/ICH-GCP知识, 自适应监查技能.2、具备治疗领域疾病知识及理解试验方案的能力。3、具备良好的沟通技巧和自如的处理人际关系,包括英语书面、口头交流能力。4、具备良好的解决问题为导向的能力。5、具备按照临床试验行业国际通行质量标准和时间节点,及时准备递交可交付成果。6、具备良好的团队工作技能和技巧。7、具备优秀的客户服务技能和技巧。8、具备良好的表达技巧和能力及判断力。9、具备良好的计算机软件及操作系统应用能力,包括Office各应用程序。10、具备与同事、领导及客户建立和维持有效工作关系的能力。1.In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines. Adaptive monitoring skills.2.Good therapeutic and protocol knowledge.3.Strong communication and interpersonal skills, including good command of English language.4.Good problem solving skills.5.Demonstrated ability to deliver results to the appropriate quality and timeline metrics.6.Good teamwork skills.7.Excellent customer service skills.8.Good presentation skills Good judgment.9.Strong software and computer skills, including MS Office applications.10.Ability to establish and maintain effective working relationships with coworkers, managers and clients.教育要求及工作经验:生命科学或相关学科学士学位及以上,至少五年临床试验工作经验,包括两年项目管理工作经验,特别是临床运营方面,或者足够的教育、培训及项目经验。Bachelor degree in life sciences or related field and 5 years clinical research experience including 2 years\ project management experience and experience in clinical operations or equivalent combination of education, training and experience.诺迈西(上海)医药科技有限公司是一家创新药物研发公司,面向全球市场。产品主要集中在重大未满足的医疗需求的中枢神经系统/疼痛、感染或肿瘤等领域,从而改善病人的生活质量。由于公司发展需求,现在公司创业团队需要招募有志之士,跟公司一起发展成长。简历请发送至邮箱 zhengye.xu@rmxbiopharma.com, 徐小姐收 职能类别: 医药技术研发管理人员 关键字: 临床项目经理

联系方式

中山西路999号华闻国际大厦

公司信息

诺迈西(上海)医药科技有限公司成立于2015年,是一家创新药物研发公司,面向全球市场。产品主要集中在重大未满足的医疗需求的中枢神经系统/疼痛、感染或肿瘤等领域,从而改善病人的生活质量。

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