Manager, Central Monitoring, Data Analysis - Poland - FSP

JOB DUTIES: 

• Act as a subject matter expert for the configuration, implementation, and execution of Central Monitoring RBQM system across studies. 

• Maintain client Central Monitoring Key Risk Indicators and Quality Tolerance Limit Libraries within Central Monitoring system to ensure standard deployment consistency and alignment with regulatory requirements. 

• Coordinate with functional and cross functional stakeholders to develop configuration specifications for Central Monitoring in system. 

• Provide operational expertise, training, and guidance as a point of escalation for Central Monitoring issues related to Central Monitoring system. 

• Conduct central monitoring reviews in support of study central monitor. 

• Participate in ongoing improvements in standardizing technologies, systems, processes, and training materials that support Central Monitoring

• Represent Central Monitoring in process improvement initiatives. 

• May require 25% travel. 

JOB REQUIREMENTS:

• Technical expertise in database design, system configuration, and report development, with experience in managing Risk-Based Quality Management (RBQM) systems or similar platforms. 

• Proficiency in programming languages such as Python, R, SQL, or SAS, with the ability to develop scripts for data analysis, automation, and system integration. 

• Strong analytical problem-solving and critical thinking 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, with the ability to collaborate across cross-functional teams and 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 Key Risk Indicators (KRIs) and Key Performance Indicators (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. 

• Preferred: Experience using CluePoints or similar centralized monitoring and risk-based quality management solutions. 

Minimal educational requirements:

• High School Diploma 

• Associates Degree 

• Bachelors Degree 

• Masters Degree 

• Ph.D.  

• PharmD 

• MD 

• Board Certified MD 

Base Pay Range for Poland: 220,000 - 250,000 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.

For an immediate interview, please contact marta.kuniewicz@parexel.com