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 (Polish proficiency is a plus)
- Proficiency in MS Office applications, Excel skills
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.