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Clinical Research Manager– Real World Study [ 投诉职位 ]

北京康斯泰克广告有限公司

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基本信息

  • 工作地点:上海市
  • 年龄要求:18~45岁
  • 要求学历:不限
  • 招聘人数:不限
  • 工作经验:3年以上
  • 专业要求:流行病学,症状诊...
  • 职称要求:不限

任职要求/岗位职责

Job Summary职位概述: - Develop product related clinical study based on overall medicalstrategies and implementation. Main Tasks & Responsibilities主要工作职责 : 1. Cooperate with medical & clinical study operation team to provideleadership and operational excellence for the execution and conduct ofreal world studies. 与医学及临床研究团队合作在真实世界研究的执行中显示卓越的领导力和专业性。 2. Lead and work with medical colleagues in study plan and protocoldesign of Rx sponsored or Investigator initiated studies. 与医学部同事共同合作并主要负责进行制药公司发起或研究者发起的临床研究计划的制定以及研究方案的撰写。 3. Manage the whole study activities, including but not limited to siteselection, Ethic's committee review, study agreement signing,investigator meeting, enrollment, trial master file management, sitemonitoring, source data varification, site close-out and study reportwriting and publication. 负责临床研究的整体实施与管理,包括但不限于研究中心选择,伦理审批,研究协议签署,研究者会的召开,入组,研究文档管理,研究中心监查,原始数据核查,研究中心关闭,研究报告的撰写和发表等。 4. Manage and track the study timeline, study budget and products ofcompany sponsored studies. 管理并跟踪公司发起研究的时间进度,研究预算和研究产品。 5. Ensure the clinical studies are in compliance with local regulations,ICH GCP and Rx SOPs. 确保所有研究符合当地法律法规的要求,ICH GCP以及Rx SOP。 6. Establish and lead local review and tracking processes ofinvestigator initiated studies. 建立相关流程并负责对研究者发起的研究进行审核和跟踪。 7. Work with Rx medical and clinical operation team to have acooperation on global multicenter studies. (Optional) 与制药公司医学部及临床研究团队合作进行国际多中心研究(可有)。 8. Establish and maintain the good relationship with KOLs, investigatorsand sites. 与意见领袖以及研究者保持良好的沟通。 Basic Requirements of the Job基本任职资格: Education& Qualifications教育背景与专业资格: - PhD or Master Degree in Clinical Medicine, Epidemiology or HEOReducation background. Experience工作经验: - Over 3 years of diverse healthcare experience in medical or clinicalresearch in pharmaceutical, medical device or CRO companies. - In-depth experience in oncology, diabetes or other chronic diseaseareas will be plus.

企业介绍

Consultech - A leading agency for pharma marketing Consultech, established in 1995, is a China-based healthcare consultingand marketing communications company. Consultech has branch offices inBeijing and Shanghai and owns a professional and experienced serviceteam. Consultech is one of the leading healthcare market consulting andmarketing communications companies in China. It creates synergy tofacilitate its clients' growth by integrating the local insights it haswith the knowledge in international practices it learned from itsexperience. The company is dedicated to working together with clientcompanies to achieve Business Success in China by providing the highestlevel strategic thinking and integrated one-stop shop services in marketresearch, strategic planning & consultancy, marketing communicationsand advertising. Consultech works with both multinational companies and local Chinesecompanies. Some of the clientele include Johnson & Johnson, MerckSharp & Dohme, Xian-Janssen, Novartis, Novo Nordisk, Merck AG,Eisai, Ipsen, China Resources Corp, Fosun Pharma, etc. 康斯公司——中国医药营销专家 康斯成立于1995年,是一家国际性的专业医药战略、营销咨询和广告策划公司。现在北京和上海两地设有业务机构,拥有专业化和丰富经验的团队。 康斯是中国早成立的医药咨询和营销传播公司之一,在市场中处于领先地位。公司的宗旨是:基于对中国医药市场的深入理解,融合国际专业理论与操作,从客户的角度思考,为医药和医疗保健公司提供包括市场调研、战略咨询、整合营销传播和广告推广策划的专业化一站式服务,帮助客户创造更大的价值。 康斯公司服务于众多跨国制药公司和本土制药企业,包括强生、诺华、诺和诺德、默沙东、卫材、德国默克、西安杨森、益普生集团、华润集团、复星医药等。 北京地址:北京市朝阳区下甸甲三号院1号楼4层尚巴创新广告园C403C室 上海地址:上海市静安区余姚路50号8号楼301室 收起

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