Central Monitoring Manager

PSI CRO

11h

About The Position

PSI is a leading Contract Research Organization with almost 30 years on the market, known for delivering quality and on-time services across various therapeutic indications. The Central Monitoring Manager role is a top priority at PSI, focusing on leading the implementation of a risk-based monitoring approach at the clinical study and program level. The primary goal is to ensure patient safety and data integrity. This position offers a unique opportunity to be at the forefront of industry advancements, establish foundational risk-based models, and gain a global perspective on projects. The company provides an extensive onboarding and mentorship program to support the manager in fulfilling tasks to the highest standards.

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 working proficiency in English
Proficiency in MS Office applications, Excel skills

Nice To Haves

Centralized Monitoring experience
German proficiency

Responsibilities

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