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CRO项目团队基本角色介绍

编辑:岁福医疗器械咨询 时间:2021-06-30 阅读量:
 

  部分名词说明

  Project Director(PD)
  Opreates as a point of escalation for both the PM and sponsor

  Project Manager(PM)
  Responsible for deliverling the project in accordance with the contract and the protocol ensuring compliance with regulations

  Clinical Lead (CL)
  Liaise with PM and CRAs,manages clinical aspects of project, primary contact for CRAs and primary in house contact for sites. Also liaises with the Project Specialist(PS)

  Project Specialist(PS):PM's Left Hand
  1.Responsible for utilizing CTMS system to track and analyze trial information(e.g. site selection,enrollment,ICF dates etc.). Will provide updates and reports to Project Leadship
  2.Participate in Kick-Off Meetings, takes meeting highlights and follows up with team on action items
  3.Senior PS can take the role as Clinical Lead

  Trial Master File Lead (TMFL)
  Provide oversight of ball electronic and/or paper TMF management activities for assigned projects and/or progarams from award to final transfer

  Lead Biostatistician
  writes and reviews statistical Analysis Plans (SAP) based on protocol, including development of well-presented mock-up displays for Tables,Listing and Figures (TLF)

  Project Financial Analyst
  Records revenue each month for Unit, Fee for service and fixed price contracts.

  Medical Writer
  Complies, writes and edits medical writing deliverables under the guidance for research scientist including: Protocols , informed Consent Form and more

  Lead Clinical Data Manager(LCDM)
  Receives verified data from CRA, looks at trends in the data, submit queries to sites

  Study start-up
  Performs assigned activities within the country;start-up of investigator sites in all phases of clinical trial

  Central Monitor(CMA)
  1.Foucus on data quality and reporting
  2.Collaborate with CRA on guidance outlined in the clinical monitoring plan

  Central risk manager
  1.Facilities the risk assessment process
  2.Coodinates cross-functional data review strategy

  当然,还有部分职位在上图中没有体现出来,欢迎大家留言区补充啦!!!

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