Central Monitoring Manager
PSI CRO
Prague, Czech republic
před 11 hodinami

Company Description

PSI is a leading Contract Research Organization with more than 25 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 :

  • 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
  • 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.

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