pm项目经理

核心职责 / Core Responsibilities 一、 项目统筹与执行策略 / Project Coordination & Execution Strategy 1. 制定并执行项目整体策略，包括里程碑设定、受试者招募、质量控制及成本控制方案。Develop and execute overall project strategies, including milestone setting, subject recruitment, quality control, and cost control plans. 2. 主导或参与核心研究文件（如方案、知情同意书、伦理文件包等）的起草、审核与交付。Lead or participate in the drafting, review, and delivery of core study documents (e.g., Protocols, ICFs, EC submission packages, etc.). 3. 主动识别并管理项目风险，制定应急预案，适时向利益相关方升级问题并跟进解决。Proactively identify and manage project risks, develop contingency plans, escalate issues to stakeholders when appropriate, and follow through to resolution. 二、团队管理与跨部门协同 / Team Management & Cross-functional Collaboration 1. 组建并带领高效、目标一致的研究团队，协调内外部资源以保障项目顺利推进。Build and lead a motivated, aligned study team, coordinating internal and external resources to ensure smooth project progress. 2. 主导/参与外部供应商的谈判与遴选；按需参与指导委员会、申报资料撰写及法规答辩等活动。Lead/participate in the negotiation and selection of external vendors; contribute to steering committees, submission assembly, and regulatory defense as needed. 3. 统筹研究者/监查员会议及团队培训，提升团队在特定疾病领域及方案执行上的专业能力。Coordinate investigator/monitor meetings and team training to enhance the team's professional capabilities in specific therapeutic areas and protocol execution. 三、质量、进度与绩效监控 / Quality, Timeline & Performance Monitoring 1. 以结果为导向，运用KPI等工具管理个人及团队绩效，确保数据完整性与受试者安全。Be results-oriented, utilizing KPIs and other tools to manage individual and team performance, ensuring data integrity and subject safety. 2. 审核CRA监查报告，进行协同访视，指导CRA解决现场问题，从多维度把控执行质量。Review CRA monitoring visit reports, conduct co-monitoring visits, and guide CRAs in resolving site issues to control execution quality from multiple dimensions. 3. 主导/支持研究中心的筛选、启动、监查及关闭全流程活动。Lead/support the full process of site selection, initiation, monitoring, and closure activities. 四、预算与合规管理 / Budget & Compliance Management 1. 负责研究预算与成本的预测、谈判、支付及发票管理，确保符合申办方及公司政策。Manage study budget and cost forecasting, negotiation, payme

/ Qualifications 一、学历与专业背景： 硕士及以上学历，临床医学、药学、预防医学或生物医药等相关专业。Education & Background: Master’s degree or above, majoring in Clinical Medicine, Pharmacy, Preventive Medicine, Biomedicine, or related fields. 工作经验： 具备2年以上化药大临床（Phase II/III）项目管理经验，熟悉新药研发全流程及临床试验各阶段操作规范，有完整参与过项目从启动到结题经验者优先。Work Experience: Minimum 2 years of project management experience in large-scale clinical trials (Phase II/III) for chemical drugs. Familiar with the entire new drug development process and operational standards of clinical trial phases; prior experience with full-cycle project management (from start-up to closeout) is preferred. 语言能力： 英语CET-6及以上水平，具备优秀的英文文献阅读、翻译及口语沟通能力，能熟练撰写英文临床研究文件及邮件。Language Skills: CET-6 or above. Excellent English reading, translation, and oral communication skills; proficient in drafting English clinical research documents and emails. 法规与专业知识： 精通中国GCP、ICH-GCP及国内外临床试验相关法律法规与指导原则；具备扎实的临床药理学或医学知识基础。Regulatory & Professional Knowledge: In-depth knowledge of China GCP, ICH-GCP, and relevant domestic/international clinical trial regulations and guidelines; solid foundation in clinical pharmacology or medical knowledge. 核心能力： 具备出色的跨部门沟通协调能力、抗压能力及突发事件解决能力；具有强烈的责任心、结果导向思维及优秀的团队领导力。Core Competencies: Excellent cross-functional communication, coordination, and problem-solving skills under pressure; strong sense of responsibility, results-oriented mindset, and outstanding team leadership. 其他要求： 熟练使用各类办公软件及项目管理工具；能适应一定频率的出差。 Others: Proficient in MS Office and project management tools; willingness to travel as required.