About the role
Job Description
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
Qualifications
* 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 * Proficiency in MS Office applications, Excel skills * Applications must be submitted in English
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 models and get a global helicopter view on each project.