Central Monitoring Manager

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.

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
• Applications must be submitted in English

• 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

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.

College/university degree or equivalent; clinical study lead/manager experience; strong communication, leadership, critical thinking, and analytical skills; ability to work with complex data; full working proficiency in English; MS Office and Excel skills.

Key Responsibilities

• leading risk management
• performing centralized monitoring
• managing study plans

Skills & Tools

Microsoft Office, Microsoft Excel

Job Details

• Category: Project and Program Management
• Seniority: Mid Level
• Commitment: Full Time
• Workplace: Remote — Tbilisi, Tbilisi, Georgia
• Languages: English

About PSI CRO

A leading Contract Research Organization with over 25 years of experience, offering quality and on-time services across therapeutic indications. — Industry: Research and Development