If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us at Manager, Central Monitoring, home-based and sponsor dedicated, in Poland.
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.
We are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success.
As the company that conducts vital clinical studies for sponsors, including the world's leading biotech’s and top 50 pharmaceutical companies, we offer you enormous security and long-term prospects.
You will work from your home office base, supporting studies within their country or region. ‘Manageable sites, manageable protocols’ is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life.
JOB DUTIES:
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.
Drive Process Improvements: Evaluate the effectiveness of Central Monitoring processes, identify areas for improvement, and recommend enhancements to tools, metrics, and methodologies.
Knowledge, skills, and abilities required to perform the job
Working knowledge of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements
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
Minimal educational requirements:
High School Diploma
Associates Degree
Bachelors Degree
Masters Degree
Ph.D.
PharmD
MD
Board Certified MD
Minimum Years of Experience:
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.
Base Pay Range for Poland: 310,000 - 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.
For an immediate interview, please contact marta.kuniewicz@parexel.com
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