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 (Spanish proficiency is a plus) Proficiency in MS Office applications, Excel skills

📌 Central Monitoring Manager. (Barcelona)
🏢 Psi
📍 Barcelona