Manager, Central Monitoring - FSP

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.

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. We are expanding our team and seeking talented individuals to help drive industry-leading innovation. With Heart®.

About The Role

We are seeking a Manager, Central Monitoring to join our Global Clinical Trial Services team in South Africa.

As a Manager, Central Monitoring, you will play a critical role in advancing clinical research by leading centralized monitoring activities for global and complex trials. You will review key risk and operational performance data and present your insights as an integral member of the clinical study team for clinical development studies. Your analysis will bring together Key Risk Indicator (KRI) and Key Performance Indicator (KPI) data housed in an analytical tool with a comprehensive review of supplemental operational data and trends, helping study teams identify and address issues that require intervention.

This position offers the opportunity to support several studies within a therapeutic area and at the program level. You will work closely with other Central Monitors and Centralized Data Risk Analysts (CDRAs) to ensure effective identification, conduct, and reporting of central monitoring activities, while contributing to continuous process improvement, innovation, 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 the Study Quality Risk Assessment by participating 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 by leading its creation, ensuring alignment with study-specific needs and Risk Based Quality Management (RBQM) methodologies.
• Oversee Central Monitoring execution by working 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 by conducting study-level Central Monitoring Reviews using data analysis tools, interpreting KRIs and KPIs, and assessing trends to identify areas requiring intervention.
• Facilitate study team decisions by presenting findings to clinical study teams, supporting root cause analysis, and providing recommendations for follow-up actions to address identified risks.
• Document and track actions by recording outputs from Central Monitoring Review meetings, tracking decisions, and ensuring the timely closure of actions.
• Act as a Central Monitoring subject matter expert by representing Central Monitoring during audits, inspections, and within study teams on RBQM processes.
• Provide oversight of Contract Research Organization (CRO) activities by partnering with outsourcing management to align monitoring strategies and ensure CRO partners execute Central Monitoring activities according to agreed standards.
• Drive process improvements by evaluating the effectiveness of Central Monitoring processes, identifying areas for improvement, and recommending enhancements to tools, metrics, and methodologies.
• Represent Central Monitoring in initiatives by contributing to cross-functional process improvement initiatives and assessing emerging technologies to enhance Central Monitoring capabilities.

This role may require 25% travel.

Candidate Profile

You'll Thrive In This Role If You Bring

• Strong analytical problem-solving and critical thinking abilities, including experience troubleshooting data refreshes and resolving execution errors in analytical systems
• Effective communication and interpersonal skills, with the ability to build relationships internally and externally
• A 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
• An aptitude for mathematical concepts, statistical methodologies, and data analytics, with a focus on interpreting KRIs and KPIs
• Proficiency in Microsoft Office applications, with advanced Excel skills for data manipulation and reporting

Required Qualifications

• Bachelor's degree
• At least 7 years of relevant experience in the biotechnology/pharmaceutical industry, with a minimum of 1 year of direct Central Monitoring experience
• Working knowledge of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements
• Knowledge and experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures

Preferred Qualifications

• Experience using CluePoints or similar centralized monitoring RBQM systems is preferred
• Site monitoring or data management experience

Benefits and Compensation 

• Premium salary.
• Attractive benefits.
• Medical care plan
• Life Assurance.
• Excellent work environment.
• Culture of teamwork and collaboration.
• People who motivate and face challenges together.
• Innovative technology.
• Excellent training.

If this job does not sound like the next step in your career, but perhaps you know someone who would be a perfect fit, send them the link to apply.

We believe in flexibility, growth, and creating space for people to do their best work.

Join us and be part of a team where your contributions help shape the future of clinical research.