Sr. Clinical Research Specialist (Sr. CRA)招聘_飞利浦（中国）投资有限公司 Philips (China) Investment Co.,Ltd.最新招聘信息-猎才医药网

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职位描述： Job descriptionSr. Clinical Research SpecialistYour challengeYour challenges are to use your clinical research skills to develop and deliver clinical evidence to internal & external stakeholders to further innovation & optimize product life-cycle with flawless execution.Your responsibilitiesAs a Sr. Clinical Research Specialist you are responsible for:?Site Monitoring & Management:oManage study activities at assigned investigational sites.oVerify the quality of the investigator and the suitability of the sites by performing study feasibility or site evaluation visit to ensure the site is qualified and suitable to conduct the study.oRe involved in the preparation of the documentation for submission to EC.oEnsure the smooth negotiation process on the site contract sign-off. Be responsible for site payment is properly paid according to the agreement.oPerform initiation, regular monitoring and close out visit to investigator site in compliance with study monitoring plan, company SOPs, local regulations and ICH GCP. Prepare and submit accurate and timely site visit reports for all performed visits.oKeep and maintenance the TMF and SRF to ensure it is up to date, complete and accurate according to company SOPs, regulations and ICH GCP.oVerify the accuracy, completeness and legibility of the data collected in the studies;oEnsure all case report forms can be collected and queries can be resolved in timely manner;oEnsure all adverse events occurred in the study be reported in compliance with study as well as regulation requirement;oVerify the trial supply is stored, transferred and tracked appropriately. And unused investigational product and other study supplies is returned or destroyed properly after the completion of study.oAssist in the preparation for the internal or external audit/ inspection. Resolve issues cited in audit reports.?Project ManagementoSet up and lead the project team to ensure the study is implemented according to company policy, SOPs and relative regulations.oPrepare the study request form and coordinate the protocol and other study documents development and approval process;oLead the project team to accomplish the proposed timeline;oCommunicate with internal and external business partner in terms of project progress and outstanding issues;oEvaluate the potential investigational sits for a specific study in terms of the qualification of the investigator and the suitability of the sites;oEvaluate the CRO, provide evaluation assessment to line manager;oActively guide and coach CRAs in the study team;oCoordinate with Data Management, Statistician and Medical Writer to ensure the deliverable on time.?Vendor ManagementoPerform vendor selection and continuous quality and compliance tracking and evaluation;oPerform effective and efficient vendor management to ensure the services vendor provided are satisfied and qualified in compliance with Philips policy, SOP and other related requirements.Your teamYou will report directly into the Sr. Manager, Clinical & Scientific Affairs-China. Clinical & Scientific Affairs China team is part of Global Clinical Affairs team, work closely with Greater China Q&R team to support the China product registration via generating the clinical evidence. You will have close interaction with Global/BU clinical team, China Regulatory affairs and other cross-functional team as well as key opinion leaders and investigators.Our offerWe offer you the opportunity to work on delivering the evidence and growing the people who contribute to it. Join us and you can provide your deep insights that accelerate innovation and drive value and safety for patients and customers everywhere.We are looking for?Bachelor’s degree & above, clinical medicine or life science preferred.?Minimum of 3 years’ experience in a pharmaceutical or medical device company for clinical research execution, including at least 1 year project management experience.?Site assessment/monitoring experience is required?Be able to collaborate effectively with the Clinical Operations team, cross-functional team members, and external partners?Demonstrated communication / interpersonal skill (oral and written).?Fluent in English reading & writing?Self-motivated individual who is able to manage multiple tasks and priorities in an efficient manner?Proactive attitude?Conscientious and precise delivery of work even when under pressure 职能类别：临床研究员

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关于我们荷兰皇家飞利浦(NYSE: PHG, AEX: PHIA)是一家世界领先的健康生活科技公司，致力于通过提供从健康的生活方式，到健康疾病的预防、诊断、治疗和家庭保健一系列的整体解决方案，提升人们的健康和生活品质。飞利浦拥有领先的科学技术以及对临床医学和消费品的独到见解，并将两者结合为人们打造整体健康生活解决方案。公司在影像诊断、图像引导治疗、患者监护、健康信息、健康生活消费品和家庭保健等等方面均居于领先地位。总部设在荷兰，皇家飞利浦拥有约69，000名雇员，在全球超过100个国家和地区设有办事处提供产品销售和服务，2015年健康科技领域的销售额超过168亿欧元。欲了解更多飞利浦新闻请访问http://www.philips.com.cn/a-w/about/news/all-news.html。加入我们，改变世界我们提供的不仅是一份工作，而是一个改善人们生活的机会。在飞利浦，您每天都会和我们一起，共同创新健康科技和解决方案，积极影响数十亿人的生活。您自己的生活也将从此改变。加入我们，您会发现自己的工作与个人生活息息相关，会获得出乎意料的成就感。我们为您的职业发展提供无限可能成为飞利浦的员工，您的人生便将开启无限可能。您的职业生涯可能会有意想不到的改变，您可能会面临意想不到的机会。或者，您可能发现您的工作所带来的意义要远远超出自己的想象。除了在工作中学习知识外，我们还为您提供针对性的指导和正式培训。欢迎加入飞利浦，探寻您的职业会给生活带来多美好的改变。您发挥***状态，我们才能成就精彩飞利浦为您提供一系列福利待遇和健康保障计划，为您的身心健康保驾护航。在这里，您既能发挥***的工作状态，又能更好地规划自己的人生。我们制定了灵活的工作制度，让您在保持高效的情况下，轻松平衡家庭与工作。我们致力于打造包容的工作环境，能够兼顾团队氛围和个人发展。我们相信，在这样一个良好的工作环境下，您可以充分发挥专长，获得职业和个人的双重成长。

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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