Sr. Clinical Research Manager

面议 上海闵行区 6-10年 本科 全职
罗氏诊断产品(上海)有限公司 2017-01-22 更新 2017-03-15 截止

Sr. Clinical Research Manager

职位描述
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. Lead a local clinical study operation team to provide leadership andoperational excellence for the execution and conduct of post-launchstudies.
领导本地临床研究团队并在上市后研究的执行中显示卓越的领导力和专业性。
2. Lead and work with medical affairs colleagues in study plan andprotocol design of company sponsored studies.
与医学事物部同事共同合作并主要负责进行公司发起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 Roche SOPs.
确保所有研究符合当地法律法规的要求,ICH GCP以及罗氏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 global MSA and clinical operation team to have acooperation on global multicenter studies.
与罗氏总部MSA及临床研究团队合作进行国际多中心研究。
8. Establish and maintain the good relationship with KOLs, investigatorsand sites.
与意见领袖以及临床研究的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 or Clinical Laboratoryeducation background.


Experience工作经验:
- Over 5 years of diverse healthcare experience in medical or clinicalresearch in pharmaceutical, medical device or IVD companies.
职位要求
  • 本科

  • 6-10年

工作地址

上海闵行区

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联系人
廖经理 china.diagnostics@roche.com
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