中央监控经理
Central Monitoring Manager
PSI 是一家领先的合同研究组织，已在市场上运营近 30 年，为客户提供稳定与创新的完美平衡，也为员工提供良好的工作环境。我们专注于在多种治疗领域提供高质量且按时的服务。
随着行业不断发展，中央监查功能已成为 PSI 的首要任务。我们正在寻找一位能够领导基于风险的监查方法在临床研究和项目层面的实施，以确保患者安全和数据完整性。
您将：
· 领导并推动初始和持续的研究风险管理
· 参与 RBM 平台的选择和搭建
· 对研究进行集中监查，包括关键风险指标的审查、统计分析和质量容限的评估
· 向研究团队和客户汇报集中监查分析结果，并在跨职能环境中管理问题
· 制定和审核研究特定的计划
· 为研究建立和管理有针对性的源数据核查（SDV）和监查策略
· 为研究建立和管理集中数据审查活动
· 为风险基于监查服务的提案和投标答辩会议提供信息支持
· 与临床数据科学组沟通研究中的挑战，并制定数据驱动的解决方案
- 大学或以上学历，或同等教育、培训和经验的组合
- 有临床研究主管/经理的经验
- 具备出色的沟通和演讲能力
- 具备领导力和独立工作的能力
- 有集中监查经验者优先
- 具备批判性思维和分析能力
- 能够处理复杂数据，并对风险报告和趋势提供洞察
- 能够适应变化并快速学习
- 熟悉临床试验的流程和职能，能够理解方案和相关研究风险
- 英语熟练（立陶宛语熟练者优先）
- 熟练使用 MS Office 应用程序，具备 Excel 技能
这个职位不仅对每个 CRO 都很重要，现在更是处于快速发展阶段。这是一个在行业前沿工作的机会，可以奠定基于风险的模型基础，并获得每个项目的全球视角。
我们提供：
· 优越的工作条件
· 丰富的培训和友好的团队
· 个人和职业发展的机会
· 起薪为 77,000 欧元的公平且具有吸引力的薪资和福利包
查看英文原文
PSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
With the industry moving forward, the central monitoring function has become a top priority at PSI. We are looking for a person, who would lead the risk-based monitoring approach implementation on the clinical study and program level to ensure patient safety and data integrity.
You will:
· Lead and facilitate initial and ongoing study Risk Management
· Participate in selection and setup of the RBM platform
· Perform Centralized Monitoring for a study including review of Key Risk Indicators, Statistical Analyses and Quality Tolerance Limits
· Present Centralized Monitoring analysis results to study teams and clients and manage issues in cross-functional environment
· Develop and review study-specific Plans
· Set up and manage targeted SDV and monitoring strategy for a study
· Set up and manage Central Data Review activities in a study
· Contribute to Proposals and bid defense meetings with information about Risk Based Monitoring services
· Communicate study challenges to Clinical Data Science group and work out data-driven solutions
- College/University degree or an equivalent combination of education, training and experience
- Clinical Study Lead/Manager experience
- Strong communication & presentation skills are essential
- Leadership and ability to work independently are essential
- Centralized Monitoring experience is a plus
- Critical thinking and analytical skills
- Ability to work with complex data and provide insight into risk reports and trends
- Ability to adapt to changing circumstances and learn quickly
- Knowledge of the process and functions in clinical trials, ability to understand the protocol and study associated risks
- Full working proficiency in English (Spanish proficiency is a plus)
- Proficiency in MS Office applications, Excel skills
- Please submit your CV/resume in English only
This role is not only important for every CRO, but it is booming now. This is an opportunity to work on a frontline of the industry, set the grounds for risk-based models and get a global helicopter view on each project.