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论文编号：	16094
作者编号：	2320234080
上传时间：	2026/6/6 16:48:55
中文题目：	A跨国合同研究组织职能服务外包部门临床监查员绩效管理优化研究
英文题目：	A Study on Performance Management Optimization for Clinical Research Associates under the Functional Service Provider Department of A Multinational Contract Research Organization
指导老师：	徐曼
中文关键字：	临床试验；合同研究组织；临床监查员；职能服务外包模式；绩效管理
英文关键字：	Clinical Trial; Contract Research Organizations; Clinical Research Associates; Functional Service Partnership; Performance Management
中文摘要：	在全球医药创新研发持续提速与中国临床试验市场快速发展的背景下，职能服务外包（Functional Service Provider, FSP）已成为跨国合同研究组织（Contract Research Organization, CRO）的核心业务形态。职能服务外包部门的临床监查员（Clinical Research Associate, CRA）采用人员归属与业务管理权相分离的双线管理结构，对绩效管理体系的设计科学性与执行有效性提出了更高要求。某跨国合同研究组织中国区职能服务外包部门采用全球统一的关键绩效指标（Key Performance Indicator, KPI）与胜任力模型双维度绩效管理体系，在框架设计、指标完整性与理论先进性上具备行业领先水平，但在实际实施过程中面临“设计先进、执行失效”的现实困境。 本文以A合同研究组织职能服务外包部门的外派临床监查员为研究对象，围绕其员工绩效管理现实问题展开调研，综合运用案例分析法、半结构化访谈法与问卷调查法，系统分析绩效体系运行现状、核心问题与深层成因。研究发现，当前体系主要存在评估周期过长、过程管理缺失、双线管理信息不对称、CRA直线经理执行能力参差不齐、绩效沟通形式化、评价结果无法区分可控与不可控外部因素等突出问题，导致绩效结果失真、公平性不足、改进闭环缺失，难以真实反映临床监查员工作价值与努力程度。 基于问题与成因分析，本文在不改变全球双维度核心框架的前提下，从周期优化、信息协同、可控/不可控因素区分、执行标准化、沟通闭环、结果应用公平化六个维度提出轻量化、可实施、本土化的优化方案，并构建组织、制度、人员、流程、文化五位一体的实施保障体系。研究结论既符合跨国企业全球管控要求，又适配中国临床研究行业现实特征，能够有效解决先进体系实施难、评价不公、过程努力被忽视等核心痛点，为同类跨国合同研究组织企业职能服务外包业务绩效管理优化提供实践参考。
英文摘要：	With the accelerated pace of global pharmaceutical innovation and R&D and the rapid development of China's clinical trial market, Functional Service Partnership (FSP) has become the core business form of multinational Contract Research Organizations (CROs). Under the FSP model, Clinical Research Associates (CRAs) adopt a dual-line management structure with the separation of personnel ownership and business management rights, which puts forward higher requirements for the scientific design and effective implementation of the performance management system. The China regional FSP department of a multinational CRO adopts a global unified dual-dimensional performance management system combining Key Performance Indicators (KPI) and competency model, which has an industry-leading level in framework design, indicator integrity and theoretical advancement, but faces the realistic dilemma of "advanced design but ineffective implementation" in the actual landing process. This paper takes the performance management of expatriate CRAs in the company’s FSP department as the research object and focuses on employee performance management. It comprehensively applies literature review, case analysis, semi-structured interviews, and questionnaire surveys to systematically analyze the current operational status, core problems, and underlying causes of the performance management system. The study finds that the current system mainly has prominent problems such as too long evaluation cycle, lack of process management, information asymmetry in dual-line management, uneven execution ability of line managers, formalized performance communication, and the inability of evaluation results to distinguish between controllable and uncontrollable external factors, leading to distorted performance results, insufficient fairness, lack of improvement closed loop, and difficulty in truly reflecting the work value and efforts of CRAs. Based on the analysis of problems and causes, on the premise of not changing the global dual-dimensional core framework, this paper puts forward a lightweight, implementable and localized optimization plan from six dimensions: cycle optimization, information coordination, distinction between controllable and uncontrollable factors, execution standardization, communication closed loop and fair application of results, and constructs a five-in-one implementation guarantee system including organization, system, personnel, process and culture. The research conclusions not only conform to the global management and control requirements of multinational enterprises, but also adapt to the realistic characteristics of China's clinical research industry, which can effectively solve the core pain points such as difficult landing of advanced systems, unfair evaluation and neglect of process efforts, and provide practical reference for the performance management optimization of FSP business of similar multinational CRO enterprises.
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