Clinical Operation Manager - Medical Device 上海

月薪： 40-60万/年

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 01-22 发布

职位描述

General SummaryThe overall purpose of the position is specified as follows,–People management and development for direct reports，includes internal and contract CRA team–Provide coaching, training and guidance to direct reports, to ensure:？Clinical trial to be conducted in compliance with GCP/SOPs, local regulatory regulations and protocols, any adverse events known from clinical trials to be reported properly project execution according to timeline and budget？Develop and maintain working relationships with others requiring interaction and mutual support–Vender (CRO) managementResponsibility？General Management (if applicable):1)People development for direct reports, perform performance review with direct reports, discuss and approve development plan for direct reports;2)Overview site management quality and process for direct reports; Support direct reports on site management;3)Review clinical research SOP and provide input on SOP revision, if applicable;4)Provide training and guidance to junior team members and business partners;？Project Management:1)Evaluate the potential investigational sites for a specific study in terms of the quality of the investigator and the suitability of the sites, if applicable;2)Actively guide and coach CRAs in the study team;3)Evaluate the CRO, provide evaluation assessment to line manager, if applicable;4)Perform co-monitoring to team members.？Monitoring (if applicable):1)Initiate, monitor and close clinical studies in compliance with study protocols and company's guidance, on budget, and on time plan;2)Document and archive all clinical trial relevant activities;3)Verify the accuracy, completeness and legibility of the data collected in the studies;4)Ensure all case report forms be collected, queries be transferred between the company and the investigators in a timely manner;5)Ensure all adverse events occurred in the study be reported in compliance with study requirements;6)Verify the trial supply to be transferred, stored and prescribed appropriately, and unused investigational products to be returned or destroyed properly？Technical / Professional Knowledge Input:1)Provide feasibility assessment and input at project planning stage based on a satisfactory level of technical and professional skill or knowledge in position related areas, if applicable;2)Provide input on training curriculum based on current developments and trends in areas of expertise.3)Provide local insight on global clinical trials, if applicable？Relationship Building:1)Build up and maintain healthy relationships with internal and external customers via smooth and efficient communications through the clinical studies2)Support the direct report to build up and maintain good relationships with study sites and internal customers, if applicable.？Vendor Management:1)Perform vendor selection and continuous quality and compliance tracking and evaluation, if applicable2)Perform effective and efficient vendor management to ensure the services vendor provided are satisfied and qualified in compliance with J&J policy, SOP and other related requirements.？Other responsibilities defined in written procedures.Qualifications:–Bachelor's degree & above, clinical medicine would be preferred–At least 5 years’ experience in clinical research execution–Strong people communication skill–Good project management skill (e.g. good planning, implementation and follow up) is preferred–Fluent in English speaking, reading and writing.–Good presentation skill–Good people management skill 职能类别： 医疗器械研发

联系方式

桂箐路65号新研大厦

公司信息

美国强生公司是世界上最大的、综合性的医药保健公司之一，也是世界上产品最多元化的公司之一。公司成立于1886年，迄今为止已在世界54个国家设有197家分公司，产品畅销全球所有国家和地区。强生公司为世界500强企业，长期以来，强生公司在各个领域获得一系列殊荣：自1986年起，强生公司被《职业母亲》杂志连年评为职业母亲的***公司。2002年被《财富》杂志评为全美最受推崇的10佳企业；被《商业周刊》评为2001年度全美***经营业绩的上市公司，2002年度全美50家表现最杰出公司榜首； 强生（中国）医疗器材有限公司系美国强生公司在中国的独资企业，从事高质量的医疗器械的生产和经营。 在翰威特公司与《哈佛商业评论中文版》联合进行的2009年亚洲***雇主调研中，强生（中国）医疗器材有限公司位列“2009年中国十佳雇主”。 因业务扩展的需要，招聘职位，在所述地点工作： 工作报酬：公司将提供有竞争力的工资及奖金，各项社保及强生公司的完善福利待遇。 为保证简历的有效性和及时性，请按照系统流程投递;但考虑到人员系统硬件的水平不同，我们也接受邮件简历 公司将在2周内通知第一批面试者。公司将对所有应聘者的个人资料予以保密。 欲查询更多强生中国医疗招聘信息，请登陆www.careers.jnj.com

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