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Central Monitoring Manager

📅 Apr 24
Risk ManagementCentralized MonitoringKey Risk IndicatorsStatistical Analyses

📜 Description

  • 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

🛠️ Requirements

  • 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
  • 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 job description

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:

    • 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

    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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