Company Description
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 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:
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Lead and facilitate initial and ongoing study Risk Management
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Participate in selection and setup of the RBM platform
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Perform Centralized Monitoring for a study including review of Key Risk Indicators, Statistical Analyses and Quality Tolerance Limits
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Present Centralized Monitoring analysis results to study teams and clients and manage issues in cross-functional environment
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Develop and review study-specific Plans
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Set up and manage targeted SDV and monitoring strategy for a study
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Set up and manage Central Data Review activities in a study
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Contribute to Proposals and bid defense meetings with information about Risk Based Monitoring services
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Communicate study challenges to Clinical Data Science group and work out data-driven solution
Qualifications
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College/University degree or an equivalent combination of education, training and experience
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Clinical Study Lead/Manager experience
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Strong communication & presentation skills are essential
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Leadership and ability to work independently are essential
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Centralized Monitoring experience is a plus
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Critical thinking and analytical skills
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Ability to work with complex data and provide insight into risk reports and trends
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Ability to adapt to changing circumstances and learn quickly
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Knowledge of the process and functions in clinical trials, ability to understand the protocol and study associated risks
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Full working proficiency in English (Italian proficiency is a plus)
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Proficiency in MS Office applications, Excel skills
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.
