Central Monitoring Manager

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…