Project Management Associate 临床项目管理专员
百济神州ShanghaiUpdate time: July 10,2019
Job Description
  • 招聘类型:社招
  • 工作性质:全职
  • 直属部门:Clinical Operations

职位描述

  • Assists COM/ACOM/SSU Lead to develop and coordinate to manage the study budget, accruals and actual cost, coordinate with CTA & CRA ensures study payments are paid on time
  • Assists COM/ACOM/SSU Lead to develop study documents and other materials
  • Coordinates vendor selection (CRO, translation, printing, travel agency, etc.) and management
  • Supports TMF related work both paper and electronic Trial Master Files (eTMF) and study SharePoint, conducts eTMF QC if needed
  • Supports PFDA document filing, CDE posting, CHGRAO submission, and ensures required documents are submitted to relevant functions/websites
  • Assists COM/ACOM/SSU Lead to organize study team meetings, including meeting room booking and setup, meeting minutes taken is required; Provides enough logistic support for investigator meetings
  • Coordinates with Clinical Supply Chain regarding drug forecasting and supply
  • Coordinates with various system account apply and management
  • Prepares and maintains various study tracker/metrics

任职条件

  • Bachelor’s level degree or above in life sciences, English and management
  • Fluent in English (listening, writing)
  • Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
  • 3 years (PMA), 5 years or above (Sr. PMA) of CTA/PMA or clinical trial experience in the Pharmaceutical or CRO industry

职位要求

  • 学历要求:本科及以上
  • 工作经验:2年以上
  • 外语要求:不需要

公司福利

  • 五险一金 
  • 晋升空间 
  • 法定节假日

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