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。