临床项目高级总监/总监 PMD

该职位来源于猎聘 岗位职责 Job responsibility: 1.1 项目经理团队建设与管理 Project manager team construction and management 1） 负责项目经理（Project Manager, PM）的招聘、培训、发展、考核与激励，制定 PM 关键交付指标，制定和实施基于风险的项目经理团队发展战略，构建人才梯队。 Be responsible for the recruitment, training, development, assessment and incentive of the project manager (PM), and to build the talent ladder for people development. To set up PM key delivery indicators and the goal for medium and long-term development of the PM team based on risk and implement in practice. 2） 负责 PM 团队的日常管理、项目分配和成本控制，确保项目管理任务高效、准确完成。 Be responsible for the daily management, study allocation and cost control of PM team 1.2 项目管理相关的质量体系建设和监督执行 Construction and supervision of quality system related to project management 1） 参与临床运营项目管理相关的质量体系建立和维护，包括 SOP、工作流程及模板的起草/审阅、定稿生效及修订，并组织 SOP 培训；负责监督和确保临床试验全过程遵循质量管理体系、法规指南及标准操作规程（SOP）; 建立质量监控指标，识别系统性风险，以保障试验数据的真实、可靠和完整性。 Participate in the establishment and maintenance of quality system related to project management of clinical operation, including the drafting/review, finalization and update of SOP, working instruction and template, and organizing SOP training. Be responsible for supervising and ensuring that the whole process of study delivery complies with the quality management system, regulatory guidelines and standard operating procedures (SOP). Establish the quality monitoring indicators, and identify systemic risks to ensure the authenticity, reliability and integrity of study data. 2） 研究状态监管：配合临床开发部门研究管理需求指导并跟进 PM 完成研究状态更新、研究层面共享文件上传、管理层定期汇报文件的准备等常规 PM团队工作。 Study status supervision: to guide and follow up the PM to complete the regular task, such as study status update, study level shared file upload, preparation of management regular report files, etc. 1.3 参与临床研究策略的沟通，为临床研究的设计和执行提供入组策略、预算和风险等临床运营方面的支持。 Participate in the communication of clinical study strategies, and provide clinical operation support such as enrollment strategy, budget and risk estimation for the design and implementation of clinical research. 1.4 带领项目经理团队完成临床研究从准备、开展至报告的全程执行，保证项目达到既定的时限、预算和质量。 Lead the project manager team to complete the whole process delivery of clinical study from preparation, recruitment to study report, and ensure that the project meets the established time limit, budget and quality. 1) 研究关键计划与关键文件管控：指导 PM 制定符合研究交付需求的研究计划（Study Timeline）并监管执行；审阅并批准根据 SOP 及工作指南审查并批准核心项目管理文件（项目计划、预算、风险计划等）；参与研究关键文件的审阅（研究方案、知情同意书等）。 Study key plan and key document control: guide the PM to develop a study timeline that meets the study delivery requirements and supervise its implementation. Review and approve core project management documents (project plan, budget, risk plan, etc.) based on SOP and work guidelines; Participate in the review of key study documents (study protocol, informed consent form, etc.) 2) 参与研究团队关键决策的讨论提供决策支持。 Participate in discussions on key decisions of the study team and provide decision support. 3) 参与关键供应商的选择，建立与维护关键供应商的定期反馈机制，确保关键 供应商的交付质量。 Participate in the selection of key suppliers, establish and maintain a regular feedback mechanism for key suppliers, and ensure the delivery quality of key suppliers. 4) 风险与问题管理：主动识别项目层面的系统性风险与问题，主导制定研究层面和研究中心层面的风险预案，协调跨部门资源完成重大升级问题的解决。 Risk and issue management: Proactively identify systemic risks and issues at the project level, lead the development of risk plans at the study and site level, coordinate cross departmental resources to solve major escalated issues. 5) 研究预算及执行监管：建立临床研究预算与实际支付的监管机制进行预算管控，并指导 PM 优化预算使用，确保成本及产出的最大化。 Study budget and execution supervision: Establish a monitoring mechanism for study budget and payment to control the budget, and guide PM to optimize budget utilization to ensure maximum cost and output. 6) 研究质量监管：建立临床研究质量监管机制进行质量管控，确保研究所有活动严格遵守 ICH-GCP 及法规要求，PM 能够主动识别质量风险，确保年度PM 协同访视及 QC 计划按照计划开展，确保 QC 及 QA 检查后制定的 CAPA有效执行。带领 PM 与 QA 及 QC 团队协同应对各类稽查与视察。 Study quality supervision: Establish the study quality supervision mechanism for quality control, ensuring that all study activities strictly comply with ICH-GCP and regulatory requirements. The PM can proactively identify quality risks, ensure that annual PM collaborative visits and QC plans are carried out according to plan, and ensure the effective implementation of CAPA formulated after QC and QA inspections. Lead the PM, QA, and QC teams to collaborate in responding to various inspections and checks. 1.5 支持临床开发部门相关的活动，包括非项目层面的团队分享、培训和质量体系建设等。 Support activities related to the Clinical Development department, including team sharing, training and quality system construction at non-project level. 1.6 完成上级领导安排的其他工作。 Complete other tasks assigned by superiors. 2 任职资格 Qualification 2.1 本科及以上学历，医学、生命科学、药学、护理学等相关专业。 Bachelor's degree or above, in medical, life sciences, pharmacy, nursing, etc. 2.2 10 年以上临床研究经验，其中至少 5 年作为全球/区域性临床项目经理（PM）的直接经验，3 年以上项目经理团队管理经验。拥有丰富的药物开发知识, 熟悉和掌握药品临床试验相关法规及 GCP 等相关规定。 More than 10 years of clinical study experience, including at least 5 years of direct experience as a global/regional clinical project manager (PM), and more than 3 years of project manager team management experience. Having rich knowledge in drug development, familiar with and proficient in regulations related to drug clinical trials and GCP regulations. 2.3 具备高效的跨部门及外部沟通协调和沟通能力和优秀的团队合作精神。 Be good at cross functional and external communication and coordination, as well as excellent teamwork spirit. 2.4 良好的决策力、影响力和执行力，以及卓越的风险管理、领导和激励团队的能力。 Good decision-making ability, influence and execution ability, as well as excellent risk management ability. Be good at leading and motivating team members. 2.5 熟练的英文口语书写阅读能力,具有海外临床研究管理经验者优先。 Good of oral and written English, and with overseas clinical study management 2.6 自驱力、自我学习和应对挑战的能力。 Self-drive, self-learning and ability to cope with challenges