Manager, Central Monitoring - Poland/Serbia/Spain - FSP in Katowice

About Parexel

Parexel is a leading global clinical development partner delivering insight-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research.

About The Role

In this role you will be accountable for centralized monitoring activities for global and/or complex trials, analytical data review of key risk and/or operational performance data and presenting as an integral member of the Clinical Study team for clinical development studies. The reviews include interpretation of Key Risk Indicator (KRI) and/or Key Performance Indicator (KPI) data housed in an analytical tool as well as a comprehensive review of supplemental operational data/trends and issues to be interpreted, reported and presented to the study teams. The Manager, Central Monitoring, will be responsible for supporting several studies within a therapeutic area and program-level. They will work closely with other Central Monitors and Centralized Data Risk Analysts (CDRAs) to ensure effective identification, conduct and reporting of central monitoring activities. This role will contribute to continued process improvement and innovation activities, and industry collaborations in central monitoring capabilities.

You will join a collaborative, growth-oriented environment where your contributions are highly visible and where continuous learning, professional development, and meaningful impact are part of everyday work.

Key Responsibilities

• Collaborate on Study Quality Risk Assessment: Participate in the development and refinement of the Study Quality Risk Assessment and Control Tracker (QRACT) to identify and manage study risks.
• Develop and Author the Central Monitoring Plan: Lead the creation of the Central Monitoring Plan, ensuring alignment with study-specific needs and Risk Based Quality Management (RBQM) methodologies.
• Oversee Central Monitoring Execution: Work with data analysts to configure, implement, and execute the Central Monitoring RBQM system across assigned studies, ensuring effective signal detection.
• Analyze and Interpret Data Trends: Conduct study-level Central Monitoring Reviews using data analysis tools, interpret KRIs/KPIs, and assess trends to identify areas requiring intervention.
• Facilitate Study Team Decisions: Present findings to clinical study teams, support root cause analysis, and provide recommendations for follow-up actions to address identified risks.
• Document and Track Actions: Document outputs from Central Monitoring Review meetings, track decisions, and ensure timely closure of actions.
• Act as Central Monitoring subject matter expert.
• Provide Oversight of Contract Research Organization (CRO) Activities: Partner with outsourcing management to align monitoring strategies and ensure CRO partners execute Central Monitoring activities according to the agreed standards.
• Drive Process Improvements: Evaluate the effectiveness of Central Monitoring processes, identify areas for improvement, and recommend enhancements to tools, metrics, and methodologies.
• Represent Central Monitoring in Initiatives: Represent the function in cross-functional process improvement initiatives and assess emerging technologies to enhance Central Monitoring capabilities.

May require 25% travel.

Candidate Profile

You'll Thrive In This Role If You Bring:

• Strong analytical problem-solving and critical thinking abilities, with experience troubleshooting data refreshes and resolving execution errors in analytical systems.
• Working knowledge of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements.
• Effective communication and interpersonal skills; ability to build relationships internally and externally.
• Demonstrated ability to identify and interpret current and future business trends and apply them to centralized monitoring practices.
• Excellent written communication skills, with the ability to convey complex technical and analytical insights in a clear and concise manner.
• Aptitude for mathematical concepts, statistical methodologies, and data analytics, with a focus on interpreting KRIs and KPIs.
• Knowledge and experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures.
• Proficiency in Microsoft Office applications, with advanced skills in Excel for data manipulation and reporting.

Minimal Educational Requirements

• High School Diploma
• Associates Degree
• Bachelors Degree
• Masters Degree
• Ph.D.
• PharmD
• MD Board Certified MD

Must Have

At least 7 years of relevant experience in the biotechnology/pharmaceutical industry, with a minimum of 1 year with direct Central Monitoring experience. Site monitoring or data management experience a plus. Experience using CluePoints is preferred.

Benefits And Compensation

Premium salary. Attractive benefits. Medical care plan: Health, Dental & Vision. Life Assurance. Excellent work environment. Culture of teamwork and collaboration. People who motivate and face challenges together. Innovative technology. Excellent training.

Base Pay Range for Poland: 300,000 - 320,000 PLN gross annual. Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel’s annual performance-based bonus plan, annual salary review and total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles.