Clinical Project Manager

Job Description
职责描述：
1、Responsible for coordinating researcher, clinical center, CRO, SMP on behalf of applicant before and after clinical trial, and control clinical trial progress and risk.
负责临床试验开展前后代表申办方与研究者、中心机构、CRO、SMO等外部机构的沟通协调，把控临床试验进度及风险；
2、Responsible for clinical trial program design and finalize program composition负责临床试验方案的设计并组织方案最后的编写；
3、Lead the team to complete design and composition of CRF, consent agreement, and program process documentation.
负责并领导团队完善CRF、知情同意书及过程性文件的设计与编写；
4、负责临床试验机构调研、筛选、考察工作；
Responsible for research, select and evaluate clinical trial center
5、Responsible for organizing meetings for clinical trials, such as meetings for trial start, pre-trial run, program completion, data analysis, data statistics, etc
项会议：启动会、预试验，完成方案、数据讨论、统计会议等；
6、负责临床试验完成后各项梳理及项目总结工作；
Responsible for consolidating and summarizing outcome after completion of clinical trials
7、Lead clinical team to complete clinical trials for registration, small clinical study and anima trials.
带领团队高质量完成各项注册临床试验、小型临床研究、动物实验等。

任职要求：
1、Minimum 4-year experience in medical device industry, and had worked and coordinated on at least 2 clinical projects. Able to work independently
四年以上有源创新医疗器械从业经验，负责过两个及以上项目的临床统筹，有独立工作能力；
2、In possession of project management experience, external communication ability and time management ability
有着项目管理经验，有丰富的对外沟通能力及时间管理能力；
3、Bachelor degree or above, major in clinical medicine (major in intentional cardiology is preferred), or bioengineering, Medical electronic engineering
本科及以上学历，临床医学（心内科优先）或者生物医学工程、医学电子工程等技术专业背景；
4、Completed GCP training with certificate and participation in CE clinical trials is preferred
GCP 受训经历及证书，以及参与过CE临床项目者优先；
5、Able to travel and work under pressure
能够承受一定工作压力，接受出差；
6、Familiarization in major hospital work flow and good work relation with PI is preferred
熟悉大医院工作流程，与各PI有密切合作经验者优先。