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    PS

    Psi Cro

    Clinical Research

    Central Monitoring Manager

    Munich, GermanyRemoteFull-timePosted 3w ago
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    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
    • 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 (German proficiency is a plus)
    • Proficiency in MS Office applications, Excel skills

    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.

    Our extensive onboarding and mentorship program will prepare you to fulfil your tasks with the highest standards, offering you:

    • Excellent and flexible working conditions.
    • A unique combination of team collaboration and independent work.
    • Competitive salary and benefits package.

    If you'd like to hear more about PSI, our organic growth and company culture, and learn more about the studies that we run and our high repeat and referral business rates, please apply for this vacancy.

    Job details are sourced from the employer's original posting.

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    About the company

    Psi Cro

    At Milestone One , we’re transforming access to clinical trials by expanding research site networks and fostering strategic partnerships with medical institutions. Our mission is to connect patients, physicians, and sponsors in a seamless ecosystem that accelerates breakthrough treatments. With over 30 years of global experience , we are a team of industry experts dedicated to quality, innovation, and collaboration. As our Operations Manager , you’ll play a key role in driving our business expansion through leading the local team and building strong, long-term partnerships with clinical research organizations and medical institutions.

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    Industry
    Clinical Research
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