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 responsiveness
Requirements:
- 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)

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。