Sr Clinical Research Manager 资深临床研究经理

面议 上海闵行区 3-5年 硕士 全职
罗氏诊断产品(上海)有限公司 2017-01-22 更新 2017-08-29 截止

Sr Clinical Research Manager 资深临床研究经理

Job Summary职位概述:
You will be responsible to develop product related clinical study basedon overall medical strategies 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.
4. Manage and track the study timeline, study budget and products ofcompany sponsored studies.
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.
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.

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.
  • 临床医学

  • 硕士

  • 3-5年

  • 不限



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