作为中国领先的提供全方位专业服务的临床研究组织，依格斯（北京）医疗科技有限公司于1999年注册成立。公司提供与药品临床开发相关的一系列专业服务，包括产品注册、项目管理、I－IV临床试验和国际多中心临床试验的监查、受试者招募、数据管理、生物统计和咨询。 基于为客户提供的优质服务，依格斯在国际前50名的跨国及国内优秀的制药公司中树立了良好的声誉。同时，依格斯与政府部门、工业界、医院、研究机构保持着广泛的接触和紧密的联系。 迄今为止，依格斯在40个城市的约130家医院进行了123个I—IV期临床研究项目，涉及病人约25，000例。中国市场吸引力的日益增强，以及依格斯团队专业化程度的不断提高，使我们对以后三年营业额的强劲增长和公司规模的持续壮大充满了信心。目前，依格斯拥有300多名优秀的员工，是中国国内规模最大的CRO公司。 依格斯的总部位于北京，在上海、广州、南京、成都、重庆、沈阳、南宁、武汉、西安、哈尔滨等城市设有办事处或服务网点。在美国和欧洲市场，依格斯设有分公司或代表处。 依格斯（泰州）疫苗临床研究有限公司是依格斯（北京）医疗科技有限公司顺应CRO行业快速发展的需要在江苏省成立的子公司，公司坐落在风景秀丽的泰州市内的中国医药城（CMC），是中国第一个专门从事疫苗和生物制品临床研究的公司。
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依格斯（泰州）疫苗临床研究有限公司 |
职位：
临床研究项目经理
汇报对象：总经理
职位要求：
- 本科其以上学历，5年以上相关工作经验
- 1个月内到位
主要职责：
1. Coordinate and supervise all aspects of implementing and conducting clinical studies in accordance with SFDA regulations, GCP/ICH guidelines, and Excel’s/sponsor’s SOPs.
2. Coach CRAs in a specific area.
3. Provide recommendation to CRAs in working skills and people development.
4. Contribute to the development of protocols and CRFs.
5. Ensure protocol compliance across all sites.
6. Participate in site selection, initiation, monitoring, and closure activities.
7. Generate clinical project plan including timeline projection and monitoring strategy.
8. May function as a project leader coordinating multi-functional project teams,may be involved in budgeting and contracts.
9. Review of CRA trip reports and correspondence.
10. Preparation and implementation of project-specific training programs and presentations for internal and external clinical team.
11. Provide leadership, guidance and mentoring to clinical team.
12. Generate regular written status reports for both internal and external use.
13. Maintain awareness of developments in the field of clinical research, GCP, and therapeutic area.
14. Make recommendations regarding monitoring safety, eligibility, enrollment,and data consistency. Organization and participation in investigator meetings,including presentations
用人要求：
1. A Bachelors Degree in a medical, health, or science related area; MS/MD preferred.
2. Minimum of 3-5 years experience in clinical research or clinical trial monitoring as a CRA in a pharmaceutical or a CRO company.
3. Minimum 2 years experience in clinical trial management.
4. Proficient in SFDA regulations and GCP/ICH guidelines.
5. Knowledge of the medical, scientific and clinical research aspects of pharmaceutical trials.
6. Knowledge and experience in clinical trial design, analysis and reporting, advanced clinical/pharmacology training preferred.
7. Demonstrated ability to write protocols, CRFs, and clinical trial reports independently.
8. Demonstrated ability to plan and organize effectively. Demonstrated ability to identify and solve problems independently.
9. Mentor and support clinical research staff.
10. Effective oral and written communication skills in English are a must. Excellent computer literacy.
11. Self-motivated and positive team player.
12. Must be able to travel if required.
薪酬待遇：
面议 预计截止时间：2024/5/12
公司简介：
京公网安备 110105001605号