CRO项目团队基本角色介绍

　　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！！！