• 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 免费班车
  • 员工旅游
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 专业培训
  • 绩效奖金
  • 定期体检

职位描述

职位描述: Responsbility:1.Oversight and project management of assigned clinical trial protocol(s) to ensure patient safety, quality and timely study execution in accordance with prevailing laws, Good Clinical Practices, and Jecho standards.2.Responsibility include: project assessment and initiation, resource procurement and planning, project implementation, leading and motivating a cross-functional team, milestone planning and tracking, ensuring production of key project progress reports, oversight of communications between Jecho and CRO, and contract and financial management.?- Protocol feasibility and site selection?- Full service CRO oversight?- Quality review site visits/co-monitoring?- Study and site management interface?- Regulatory / ethics / health authority responsibilities?- Inspection readiness, compliance and audit responsivenessRequirements:- A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology:BSc/MSc/ Ph.D./MD or equivalent;- Solid knowledge of clinical development processes;- Site Management/Monitoring (CRA) experience,CRO management experience is preferred;- Project management experience in the clinical development area;- 3-6 years of clinical research experience;- Demonstrated knowledge of clinical research processes and regulatory requirements; ability to gain command of process details- Knowledge and demonstrated success in training and implementation- Demonstrated ability to manage complex projects and cross-functional processes required- Highly proficient verbal and written communication skills (Chinese and English) 职能类别: 药品市场推广主管/专员

联系方式

滨海新区中新生态城中天大道1620号研发大厦

公司信息

杰科(天津)生物医药有限公司是一家中美合资的生物制药公司,坐落于天津中新生态城。公司正在筹建包括研发、中试、质控及GMP生产等功能的大型生产基地,并陆续从国内外招聘优秀人才,组建一流的研发及生产团队。公司正在筹建的是中国规模最大之一的生物药物生产设施,其研发、生产及质量控制等设施均达到欧美设计建造标准。第一期工程将在三年内投产运行。杰科生物预计未来一期、二期共建设十条生产线,满足十多个生物药物的大规模GMP生产,达到1000-1500人的规模,产品包括单克隆抗体、抗体融合蛋白、细胞因子、重组蛋白或DNA疫苗等。

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