苏州招聘

职位描述：
岗位职责：
1. 负责临床项目的开展和协调等；
2. 设计、编写、制作临床试验方案和CRF的设计、研究者手册与试验相关资料；
3. 开展研究单位的调研筛选、协议谈判，召开临床试验各阶段会议；
4. 负责临床试验的实施和监查工作，确保研究者按照方案、GCP、SOP等相关要求进行试验，确保试验符合伦理要求、试验数据科学可靠并及时收集，确保研究中心按照时间表完成病例的入组和统计工作，负责临床总结报告的撰写；
5. 掌握各中心临床进度，督促临床方案实施，及时妥当处理AE和SAE，解决产品临床试验过程中出现的问题并处理临床数据；
6. 按照监查计划定期对研究中心进行实地监查，并在规定的时间内完成监查报告，同时将访视的详细情况报告上级，使上级随时了解试验执行过程中的情况，及时发现和改正存在的问题；
7.与临床医院及相关临床试验人员保持良好的关系。

任职资格：
1、临床,护理或药学相关本科以上学历
2、有3年以上临床监查相关工作经历，有三类医疗器械经验者优先考虑
3、了解掌握GCP及临床相关法律法规；
4、沟通能力强、有团队合作意识 举报 分享

渊资是医药、化工、食品行业里产品研发，工厂建设及运营管理方面的专业工程、技术服务组织。
As a professional engineering & technology service provider for Pharmaceutical, Medical, Chemical and Food industry, YANZ services its clients in the aspects such as research and development of new products; engineering and construction of new factory; operations management of existing factory.

在产品研发领域，我们与客户一起致力于开发流程、实验项目与实验中心的标准化及国际化；帮助客户提高产品质量，加快研发速度，降低开发成本，从而为客户获得***的经济效益。
In the field of new product research & development, YANZ accompanies its clients for the standardization & internationalization of development procedure, experimental program and experiment center. At the same time, YANZ help client maximum the economic benefits by improving product quality, accelerating development progress and reducing of development cost.

在工厂建设领域，我们提供从项目选址、可行性研究、设计、采购、施工到设备安装、调试、验证的全方位工程及项目管理服务。无论项目大小、改扩建、高低端、内外资，我们都确保客户的需求在平衡质量、成本及进度的前提下得到***满足。
In the field of new factory engineering and construction, YANZ provides engineering and project management service for example project location alternatives, feasibility study, plant concept engineering, facilities detail engineering, procurement support, construction management, commissioning & qualification management etc. YANZ ensures all user requirements will be well implemented during execution no matter the project are big or small, greenfield or renovation, high or low end, foreign or local investment.

在运营管理领域，我们既帮助客户创建新的体系，制定新的规则、计划、程序及流程；亦利用我们手里的创新工具对已有生产、质量、维护体系及物流系统进行诊断，评估，进而 帮助客户进行快速改进，从而全方位提升工厂的经营能力。
In the field of existing factory operations management, YANZ help client to create new system and establish new regulation, schedule, procedure and process. Also, YANZ help client diagnose & assess its existing manufacturing, quality, maintenance and logistics management system by utilizing innovative tools, and to provide improvement solution subsequently.

咨询行业里从不缺乏高屋建瓴，点石成金的大师，但这并不是渊资所要探索的。渊资的追求在于应用自己手中所积累的经验，素材，在自己熟悉和擅长的领域里解决客户各类实实在在的工程、技术需求，并从而与客户共同发展。
There’s never lack of high level masters on the consulting market who have farsightedness and can turn stone into gold, but this is not what YANZ looking for. Our target is to accompany with clients to solve all kinds of real engineering & technology issues based on accumulated experience in dedicated industries and to get YANZ developed accordingly.

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