Company Description

PSI CRO AG is a prominent Contract Research Organization with nearly three decades of experience in the industry. Our mission is to provide a harmonious blend of stability and innovation, benefiting both our clients and employees alike. We are dedicated to delivering high-quality services within various therapeutic areas, emphasizing punctuality and excellence in all our endeavors.

Job Description

As the industry progresses, central monitoring has emerged as a key focus for PSI. We are seeking an individual to take on the role of Central Monitoring Manager, overseeing the implementation of a risk-based monitoring approach at both clinical study and program levels. The primary objective of this position is to safeguard patient safety and ensure data integrity throughout the research process.

Responsibilities include leading and facilitating initial and ongoing study Risk Management, participating in the selection and setup of the RBM platform, conducting Centralized Monitoring activities such as reviewing Key Risk Indicators and Statistical Analyses, presenting analysis results to study teams and clients, managing cross-functional issues, developing study-specific Plans, setting up targeted SDV strategies, managing Central Data Review activities, contributing to proposals and bid defense meetings regarding Risk Based Monitoring services, as well as communicating study challenges to Clinical Data Science groups.

Qualifications

The ideal candidate will possess a College/University degree or equivalent education/training/experience along with Clinical Study Lead/Manager experience. Strong communication & presentation skills are essential for this role. Leadership qualities and the ability to work independently are crucial. Previous experience in Centralized Monitoring would be advantageous. Critical thinking abilities, analytical skills, adaptability to changing circumstances, quick learning aptitude, knowledge of clinical trial processes/functions/protocols/risks, proficiency in English (Estonian proficiency is a plus), as well as proficiency in MS Office applications particularly Excel are required.

This position holds significant importance within every CRO organization currently experiencing rapid growth. It presents an exciting opportunity to be at the forefront of the industry's advancements by establishing risk-based models while gaining a comprehensive global perspective on each project undertaken.

We invite talented individuals with Clinical Study Lead/Manager backgrounds who possess strong leadership skills and an interest in central monitoring functions to apply for this pivotal role that offers ample room for professional growth and development within our esteemed organization.

Key Job Requirements:

• Clinical Study Lead/Manager experience
• Centralized Monitoring experience
• Experience in Risk Based Monitoring services
• College/University degree or equivalent
• Strong communication & presentation skills
• Critical thinking and analytical skills

Key Job Responsibilities:

• Lead and facilitate initial and ongoing study Risk Management
• Perform Centralized Monitoring for a study including review of Key Risk Indicators
• Set up and manage targeted SDV and monitoring strategy for a study
• Contribute to Proposals and bid defense meetings with information about Risk Based Monitoring services

Skills:

• Risk-based monitoring approach implementation
• Clinical trials process knowledge
• Data analysis skills
• Communication skills
• Leadership skills

Seniority Level: Senior Level

• Lead
• Manager

Job Functions: Operations

• Risk Management
• Clinical Data Science

Industries : Healthcare

• Contract Research Organization
• Clinical Trials