Central Monitoring Manager (m/f/d)

• 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 theprocessand functions in clinical trials, ability to understand the protocol and study associated risks
• Full working proficiency in English (German proficiency is a plus)
• Proficiency in MS Office applications,Excel skills
• Additional Information
• 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 modelsand get a global helicopter view on each project.

• Our extensive onboarding and mentorship program will prepare you to fulfil your tasks with the highest standards, offering you:
• Excellent and flexible working conditions.
• A unique combination of team collaboration and independent work.
• Competitive salary and benefits package.

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.