Central Monitoring Manager

PSI CRO; Remote; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading clinical research organization in Munich is seeking a skilled individual to lead risk-based monitoring in clinical studies. The role involves facilitating study risk management, conducting centralized monitoring, and presenting analysis results. Candidates should possess a university degree, experience in clinical study management, and strong communication skills. The organization offers competitive salary and excellent working conditions, with opportunities for remote work.

Leistungen

Flexible working conditions

Competitive salary and benefits package

Extensive onboarding and mentorship program

Qualifikationen

• Clinical Study Lead / Manager experience.
• Ability to adapt to changing circumstances and learn quickly.
• Full working proficiency in English; German proficiency is a plus.

Aufgaben

• Lead and facilitate study Risk Management.
• Participate in the selection and setup of the RBM platform.
• Present Centralized Monitoring analysis results to study teams.

Kenntnisse

Leadership

Strong communication skills

Critical thinking

Analytical skills

Proficiency in MS Office

Ability to work with complex data

Ausbildung

College / University degree

Jobbeschreibung

Overview

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 (German 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 modelsand 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 youd 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.

Remote Work

Yes

Employment Type

Full-time