Skills this job asks for
Risk managementStatisticsLeadershipEnglishExcel
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Where you can work from
Europe only
Based on the listing's location: Budapest, HU (Remote).
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Sponsorship verdict
No sponsorship evidence yet
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Before you apply
Sponsorship unknown
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About the role
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
• Proficiency in MS Office applications, Excel skills
• Applications must be submitted in English
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.
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Budapest, HU (Remote) ·