Job Description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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, Data Analysis, home-based and sponsor dedicated, in Poland

In this role you will be responsible for overseeing centralized monitoring activities for global and/or complex clinical trials, ensuring the effective configuration, execution, and maintenance of Risk-Based Quality Management (RBQM) systems. This role involves configuring studies within an RBQM platform, performing recurring data refreshes, troubleshooting errors in execution, and leveraging programming expertise to support advanced data analyses, automation, and reporting.

The Manager will play a critical role in interpreting and presenting Key Risk Indicator (KRI) and Key Performance Indicator (KPI) data, as well as conducting comprehensive reviews of supplemental operational data, trends, and issues. Proficiency in programming languages such as R, SQL, or SAS will be essential for creating custom analyses, automating workflows, and integrating data systems. As an integral member of the Central Monitoring team, the Manager will deliver actionable insights to drive decision-making and optimize trial performance.

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:

• 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