默克药厂
Clinical Site Management Excellence Lead (all genders)
Clinical Site Management Excellence Lead (all genders)
发布于 4 小时前中层管理(经理/总监)
AI 估算 · 6.5–9.5万 · AI 参考估算
Feltham, London, United Kingdom
高级经验
硕士
全职员工混合式弹性办公临床研究
临床研究
Clinical Research
Cross-Functional Leadership
Gcp Compliance
Ich-Gcp
Process Improvement
值不值得投
85综合评分
综合评分 85
Senior clinical management role at a multinational pharma company with strong purpose, broad development opportunities, and hybrid work but requiring international travel.
从薪资福利、成长发展、工作生活和使命价值四个维度综合评估，方便横向比较。
薪资怎么样
8万
比临床研究中位数高
发布情况
新岗位 · 今天发布
公司情况
这家公司招聘很活跃
60 个在招
市场机会
选择面较广
临床研究 · 约 570 个在招
职位详情
关于这个职位
该职位负责推动临床试验监查和研究中心管理的卓越运营，确保全球流程的标准化与合规
你需要作为内部顾问，与区域和全球团队紧密合作，优化研究中心管理策略，支持去中心化试验和基于风险的监查等现代临床试验模式
最低要求
拥有生命科学、医学、临床研究或相关领域的高级学位，或具备同等的专业经验
具备12年以上临床研究经验，在全球环境中拥有深厚的研究中心管理和临床监查专业知识
拥有在受监管环境中负责端到端临床流程（包括流程设计、文档编制、绩效监督和持续改进）的成功记录
精通 ICH-GCP 指南（包括 ICH E6(R3)），并在应用质量源于设计（QbD）和基于风险的质量管理原则方面经验丰富
曾在复杂的矩阵组织中领导跨职能倡议，在没有直接职权的情况下，在多元化团队、CRO 和供应商之间建立共识
曾与技术及数字化团队合作，制定系统需求并推动支持流程合规和运营效率的工具的采用
运用强大的分析和数据驱动方法，将绩效指标转化为针对性的流程改进
适应全球化、多元文化的环境，并愿意接受高达20%的国际差旅
工作职责
作为战略和运营领导者，推动临床试验监查和研究中心管理活动在规划、执行和监督方面的卓越表现
确保临床监查和研究中心管理实践在全球范围内协调一致、随时准备接受检查，并能响应不断发展的试验模式（包括去中心化试验、基于风险的监查、远程和集中监查、数字健康集成以及不断发展的研究中心协调需求）
以临床监查策略为核心，定义研究中心管理如何在实践中有效实施该策略，涵盖研究中心启动、初始化、监查、持续监督、升级、问题管理、CAPA 关联和结束等全过程
协调不同职能如何在国家、区域/集群和全球层面与研究中心互动，确保清晰的沟通、明确的角色、一致的研究中心参与方式，以及在 GDO 和 R&D 同行、区域和集群负责人、研究团队、CRO、供应商及其他与研究中心对接的职能之间保持一致的工作方式
作为内部顾问和转型领导者，与区域和集群负责人、GDO 同行、相关研究成员及面向研究中心的职能紧密合作，塑造并实施可扩展、高效且符合 GCP 的临床监查和研究中心管理流程
确保这些流程符合监管期望、组织目标以及现代临床试验交付的需求
AI 洞察
优缺点分析
优点
- Merck, as a top global pharmaceutical company, offers a broad international perspective and a diverse, inclusive work environment.
- Involvement in the transformation of cutting-edge clinical trial models (e.g., decentralized trials) provides high industry foresight and personal achievement.
- Leading complex matrix organizations without direct authority requires significant cross-departmental coordination and change management skills.
- International travel (up to 20%) and navigating multi-country regulatory compliance can bring certain work pressures.
- Ideal for seasoned professionals with extensive global clinical research experience, excellent cross-functional coordination skills, and a strategic mindset to drive clinical operations transformation in a top pharma company.
缺点 / 挑战
暂无明显挑战项
角色解读
- Progress towards Global Clinical Operations Director, Head of Clinical Trial Centers of Excellence, or higher-level R&D management roles.
- Drive the excellence of global clinical trial monitoring and site management strategies, ensuring processes comply with GCP and regulatory requirements.
- Act as an internal consultant to promote the implementation of modern clinical trial models, such as decentralized trials and risk-based monitoring.
- Over 12 years of clinical research experience with deep expertise in ICH-GCP guidelines and risk-based quality management.
- Strong cross-functional leadership, data analysis capabilities, and the ability to drive digital transformation in clinical operations.
申请策略
- Demonstrate alignment with Merck's 'United As One for Patients' purpose and adaptability to working in a global, multicultural team in your cover letter or interview.
- Highlight successful experiences in leading cross-functional projects within a matrix organization without direct authority.
- Emphasize specific achievements in process design, compliance oversight, and driving the adoption of digital tools.
- Gain a deeper understanding of the latest industry trends and regulatory dynamics in Decentralized Clinical Trials (DCT) and Risk-Based Monitoring (RBM).
- Enhance data analysis skills and the ability to translate performance metrics into actionable process improvements.
面试指南
- Use the STAR method (Situation, Task, Action, Result) to structure answers for behavioral questions.
- When answering professional questions, support your points with ICH-GCP guidelines and specific project data.
- Can you share an example of how you successfully led a cross-functional team to achieve a goal without having direct authority?
- How do you apply risk-based quality management principles to your actual clinical monitoring strategy?
- What compliance or operational challenges have you faced when driving decentralized trials or digital health integration, and how did you resolve them?
- Review the latest revisions of ICH E6(R3) and their impact on clinical monitoring.
- Understand Merck's latest clinical trial pipelines in oncology, neurology, and fertility.
职位点评
薪资福利85
成长发展90
工作生活75
使命价值90
薪资福利
85较高
As a senior management role in a multinational pharmaceutical company, the compensation and benefits are at a higher industry level, though specific figures are not disclosed in the JD.
薪资信号未披露（AI估算：6.5千–9.5万/月）
成长发展
90较高
The role involves transformation in cutting-edge clinical trial models, providing global exposure and cross-functional leadership development, with rich opportunities for personal and career advancement.
技术前沿前沿/新兴技术
技术栈Decentralized Trials、Risk-based Monitoring、Digital Health Integration、ICH-GCP、Quality by Design
成长机会personal development、career advancement
业务类型ambiguous
工作生活
75中等
The JD explicitly offers a hybrid working model (3 days on-site) and emphasizes a flexible working culture, though it requires up to 20% international travel.
工作模式混合式弹性办公
办公地点郊区/偏远地区
加班情况未提及（无法判断）
工作生活平衡flexible working culture
使命价值
90较高
Merck is dedicated to creating, improving, and prolonging lives, developing innovative medicines in key therapeutic areas like oncology and neurology, offering high social value.
行业发展高速增长赛道
社会影响正向社会影响力较高
使命信号help create, improve and prolong lives、champion human progress
创新程度积极采用新技术
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