Central Monitoring Manager

Role Summary

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.

Responsibilities

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 (Latvian 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.
• 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.

About the Company

Why Join PSI?

At PSI, we believe exceptional people deserve an exceptional workplace.

When you join PSI, you'll benefit from

A stable, privately held CRO that has never undergone a merger or acquisition and has never experienced company-wide layoffs.

A unique leadership-focused CRA role with minimal travel and little to no routine site assignments.

Opportunities to mentor other CRAs and expand your leadership skills.

A collaborative, people-first culture where employees are genuinely supported.

Career development opportunities across a growing global organization.

The chance to contribute to innovative clinical research that improves patients' lives.

We are the company that cares - for our staff, our clients, our partners, and the quality of the work we do.

Founded in 1995, PSI CRO is a privately owned, global Contract Research Organization with more than 3,000 employees dedicated to advancing medical science and bringing new therapies to patients worldwide.

In an industry shaped by mergers, acquisitions, and restructures, PSI stands apart. We have remained privately held, have never undergone a merger or acquisition, and have never experienced company-wide layoffs. Our long-term stability allows us to invest in our people, foster meaningful careers, and build lasting partnerships with our clients.

If you're looking for a collaborative organization where you can continue to grow while making a meaningful impact, PSI is the right place for you.