上海招聘

职位描述：
负责公司进口二、三体外诊断器械及试剂的临床试验组织及管理工作，具体职责包括但不限于：
In charge of the whole clinical trial progress for IVD products (Both device and reagent) which include but not limited to:
1．制定项目管理计划，临床医院的甄选、跟进，临床方案的撰写、制定
Prepare clinical project management plan, select and validate project center, follow up, and compose trial proposal
2． 负责临床研究项目的质量监控和管理工作，确保临床项目符合公司要求和国家法规要求；
Manage and supervise trial’s quality and ensure all that is done in compliance with company standards and governmental regulation
3．确保临床试验有效执行，符合预算和时间的要求，达到病例入组的标准。
Pro-active trial management to identify challenges, develop effective mitigation plans and to appropriately escalate and inform all relevant parties.
4．能后做好前瞻性的临床试验管理，预见可能出现的问题并有效地解决问题，适时适度告知相关人员；
Ensuring clinical trials are effectively executed and completed within budget, timelines and meeting enrollment commitments.
5．支持研究者会议，及时处理与项目中心的沟通工作，完成领导交代的其他工作。
Support investigator meetings and communicate with clinical sites in dealing with issues, and appropriate handle other tasks assigned by managers.

任职要求：
1．本科或以上学历，医学相关专业，5年以上项目管理经验
Bachelor degree or above with medical related major, and at least 5 years project management working experience
2．熟悉临床项目工作流程
Familiar with clinical project procedures
3．良好的中英文沟通表达能力及团队合作精神；
Good communication both in Chinese and English, good interpersonal skills, and team work inspirit
4．良好的计划、组织和解决问题的能力。
Good planning, organization and problem-solving capability
5. 熟悉体外诊断产品临床试验各要求，包括器械及试剂
Familiar with clinical trial requirements for IVD products which include both medical device and reagents
6. 英语听说读写流利
Fluent in English written and spoken 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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