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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。
