PSI CRO

Global CRO delivering on-time patient enrollment

Central Monitoring Manager

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeVilnius, Vilnius City Municipality, Lithuania€77kRemote

About the Job

Requirements

A college/university degree or an equivalent combination of education, training, and experience is required.
Clinical Study Lead or Manager experience is required.
Strong communication and presentation skills are essential.
Leadership ability and the ability to work independently are essential.
Critical thinking and analytical skills are required.
The ability to work with complex data and provide insight into risk reports and trends is required.
The ability to adapt to changing circumstances and learn quickly is required.
Knowledge of clinical-trial processes and functions, including the ability to understand protocols and study-associated risks, is required.
Full working proficiency in English is required.
Proficiency in Microsoft Office applications, including Excel, is required.

Responsibilities

Lead and facilitate initial and ongoing study risk management.
Participate in selection and setup of the risk-based monitoring 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 a cross-functional environment.
Develop and review study-specific plans.
Set up and manage targeted source data verification and a study monitoring strategy.
Set up and manage central data review activities in a study.
Contribute information about risk-based monitoring services to proposals and bid defense meetings.
Communicate study challenges to the Clinical Data Science group and develop data-driven solutions.

Desired Qualifications

Centralized Monitoring experience is a plus.
Lithuanian proficiency is a plus.

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 (Lithuanian 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.

We offer:

Excellent working conditions
Extensive training and friendly team
Opportunities for personal and professional growth
A fair and attractive salary and benefits package starting at EUR 77.000 gross. The precise salary depends on the specific qualifications and experience, and will be agreed upon on an individual basis.

About the Company

PSI CRO

Global CRO delivering on-time patient enrollment

PSI CRO is a global contract research organization that handles clinical trials for multiple therapeutic areas, with a focus on enrolling patients on schedule and delivering studies on time. Its services span feasibility assessments, trial planning, site selection, patient recruitment, and multi-continent trial execution across 50+ countries, backed by medical doctor resources dedicated to accurate timeline predictions. Unlike many CROs, PSI emphasizes predictable enrollment and on-time project delivery, aiming for high client satisfaction and repeat business through a pragmatic, no-nonsense approach. The company’s goal is to be regarded as the best CRO in the world by both clients and employees, achieved through reliable timelines, strong execution, and low staff turnover.

Company size: 1,001-5,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Switzerland
Founded: 1995

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