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论文编号：	13574
作者编号：	2320190536
上传时间：	2022/12/4 20:09:22
中文题目：	临床前CRO行业X公司专题负责人管理能力提升研究
英文题目：	Research on Improvement of Management Ability of the Study Director in the Pre-clinical CRO Company X
指导老师：	袁庆宏
中文关键字：	新药研发；临床前CRO；专题负责人；管理能力；能力提升
英文关键字：	New Drug R&D; Pre-clinical CRO; Study Director; Management Ability; Improvement of Ability
中文摘要：	近年来，在政策、资本、技术等多重驱动因素利好的形势下，我国医药行业对新药研发的重视程度和资源倾斜程度达到了前所未有的高度。国内新药研发产业的高速发展带动了整个CRO（Contract Research Organization, 合同研究组织，简称CRO）行业，其中的临床前CRO行业迅速崛起，成为备受瞩目的新星。X公司是一家典型的临床前CRO公司，拥有深厚的技术积累和丰富的项目经验，具备成长为行业领军企业的潜力。愈发激烈的行业竞争给X公司业绩增长带来巨大压力，而研发项目的绩效对于X公司的业绩至关重要。 临床前研究服务中的非临床安全性评价研究服务是X公司的核心业务，专题负责人作为此类研发项目的直接管理者，肩负着保证项目方案合理、质量合规的重任，是临床前CRO公司最关键的职位之一。随着临床前CRO行业的发展，专题负责人管理能力对研发项目绩效的影响作用愈加凸显。但目前X公司专题负责人能力建设中“重技术能力，轻管理能力”的倾向明显，存在诸多具体问题，专题负责人管理能力提升已成为X公司发展中值得高度关注的关键课题。 本文以X公司专题负责人管理能力为研究对象。从人力资源、研发项目管理等方面对X公司专题负责人现状进行了全面分析。通过分析公司战略和研发项目内外部的新变化，调研专题负责人管理能力现状及目前影响专题负责人管理能力提升的问题，强调专题负责人管理能力提升的必要性。针对目前的问题，提出X公司专题负责人管理能力提升的体系优化建议：建立管理能力评价标准，明确管理能力提升目标，优化管理能力提升路径，完善管理能力认证。最后，从制度建设、组织管理、文化建设等方面提出保障条件。本文围绕X公司专题负责人管理能力提升开展研究，希望能够解除其管理能力提升的掣肘因素，以改善研发项目管理绩效，切实推动公司业绩增长。
英文摘要：	In recent years, under the situation with multiple and favorable driving factors such as policies, capital, technology, Importance and resource inclination to new drug R&D has achieved an unprecedented degree in the industry of our country. The rapid development of the domestic new drug R&D industry has accelerated the entire CRO industry, among which the pre-clinical CRO industry has risen abruptly and become an eye-catching nova. Company X is a pre-clinical CRO company with profound accumulation. It has advantages in many fields and has the potential to grow into one of the industry leaders. However, the increasingly fierce industry competition has brought great pressure to the performance growth of company X. The performance of R&D projects is crucial to the performance of company X. Non-clinical safety evaluation service in the pre-clinical research service is the core business of company X, as one of the most critical positions in the pre-clinical CRO company, the study director of R&D projects has been responsible for the technicality and compliance of pre-clinical research. With the development of pre-clinical CRO industry, as the direct manager of R&D projects of pre-clinical CRO companies, the management ability of the study director is increasingly important for the performance of R&D projects. However, at present, in the capacity building of the study director of company X's R&D projects, there is an obvious tendency of "focusing on technical ability, ignoring management ability", and there are many specific problems. The improvement of the management ability of the study director has become a key issue worthy of high attention in the development of company X. This thesis took the management ability of the study director in company X as the research object. It comprehensively analyzed the current situation of the study director from the aspects of human resource and R&D project management. By analyzing the strategy and the new changes inside and outside the R&D projects of company X, as well as investigating the current situation and the problems that currently affect the improvement of the management ability of the study director, it emphasized the necessity of the improvement of the management ability of the study director. In view of the current problems, this thesis proposed the suggestions on system optimization for the improvement of the management ability of the study director in company X: to establish the evaluation criteria for the management ability, to define the target for the improvement of the management ability, to optimize the path for the improvement of the management ability, and to improve the certification for the management ability. Finally, the guarantee conditions were proposed from the aspects of system construction, organization management and cultural construction. Through the research on improvement of management ability of the study director in company X, this thesis hoped remove the limiting factors to the improvement of their management ability, so as to improve the management performance of the R&D projects and effectively promote the growth of the company's performance.
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