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Central Monitoring Manager
Warsaw , Poland
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2700 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.
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.
- 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 and Polish
- Proficiency in MS Office applications, Excel skills
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. Advance your career in clinical research and develop new skillsets whilst growing with the organization!