職位描述
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 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)
企業(yè)介紹
是一家中美合資的生物制藥公司，坐落于天津中新生態(tài)城。公司正在籌建包括研發(fā)、中試、質(zhì)控及GMP生產(chǎn)等功能的大型生產(chǎn)基地，并陸續(xù)從國內(nèi)外招聘優(yōu)秀人才，組建一流的研發(fā)及生產(chǎn)團隊。公司正在籌建的是中國規(guī)模最大之一的生物藥物生產(chǎn)設(shè)施，其研發(fā)、生產(chǎn)及質(zhì)量控制等設(shè)施均達(dá)到歐美設(shè)計建造標(biāo)準(zhǔn)。第一期工程將在三年內(nèi)投產(chǎn)運行。杰科生物預(yù)計未來一期、二期共建設(shè)十條生產(chǎn)線，滿足十多個生物藥物的大規(guī)模GMP生產(chǎn)，達(dá)到1000-1500人的規(guī)模，產(chǎn)品包括單克隆抗體、抗體融合蛋白、細(xì)胞因子、重組蛋白或DNA疫苗等。
