PSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.Job DescriptionWith 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 solutionsQualifications- 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 skillsAdditional InformationThis 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 general helicopter view on each project.#J-18808-Ljbffr

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