Central Monitoring, Manager
WFA Digital Insight
The demand for skilled professionals in clinical trial management has grown significantly, with a 25% increase in job openings in the past year. Parexel, a leading player in the industry, is now seeking a Central Monitoring Manager to oversee global trials. With at least one year of direct central monitoring experience required, this role is ideal for seasoned professionals looking to take their careers to the next level. As the industry continues to evolve, companies like Parexel are at the forefront of innovation, making this an exciting time to join their team. Before applying, candidates should be prepared to demonstrate their expertise in central monitoring, data analysis, and risk management.
Job Description
About the Role
The Central Monitoring Manager is a critical role at Parexel, responsible for overseeing centralized monitoring activities for global and complex clinical trials. This position requires a deep understanding of clinical trial management, data analysis, and risk management. The successful candidate will be an integral member of the Clinical Study team, working closely with cross-functional teams to ensure the effective execution of clinical trials.As a Central Monitoring Manager, you will be responsible for analyzing and interpreting complex data sets, identifying trends, and presenting findings to clinical study teams. You will also collaborate with other Central Monitors and Centralized Data Risk Analysts to ensure the effective identification, conduct, and reporting of central monitoring activities.
Parexel is committed to improving the world's health, and this role plays a critical part in that mission. The company's values are centered around a deep conviction in what they do, and every employee contributes to the development of therapies that ultimately benefit patients.
What You Will Do
- Develop and implement centralized monitoring plans, ensuring alignment with study-specific needs and Risk-Based Quality Management (RBQM) methodologies
- Oversee the execution of central monitoring activities, including data analysis, trend identification, and signal detection
- Present findings to clinical study teams, supporting root cause analysis and providing recommendations for follow-up actions
- Collaborate with other Central Monitors and Centralized Data Risk Analysts to ensure effective identification, conduct, and reporting of central monitoring activities
- Develop and maintain study quality risk assessments, identifying and managing study risks
- Work with data analysts to configure, implement, and execute the Central Monitoring RBQM system across assigned studies
- Analyze and interpret data trends, assessing study-level Central Monitoring Reviews and identifying areas requiring intervention
- Facilitate study team decisions, providing recommendations for follow-up actions to address identified risks
- Document and track actions, ensuring timely closure of actions and decisions
- Act as a subject matter expert in Central Monitoring, representing the function in audits, inspections, and study teams
What We Are Looking For
- At least one year of direct central monitoring experience
- Strong analytical and problem-solving skills, with experience troubleshooting data issues
- Working knowledge of clinical trial management, including ICH, GCP guidelines, and regulatory requirements
- Effective communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams
- Experience with data analysis tools and software, including Excel
- Strong attention to detail, with the ability to analyze and interpret complex data sets
- Experience with risk management and quality assurance
Nice to Have
- Experience with Central Monitoring RBQM systems and tools
- Knowledge of therapeutic areas and clinical trial design
- Experience with outsourcing management and CRO partnerships
- Certification in clinical trial management or a related field
- Experience with process improvement initiatives and innovation activities
Benefits and Perks
- Competitive salary and benefits package
- Opportunity to work with a leading player in the clinical trial management industry
- Collaborative and dynamic work environment
- Professional development opportunities, including training and education
- Flexible work arrangements, including remote work options
- Access to cutting-edge technology and tools
- Recognition and reward programs for outstanding performance
How to Stand Out
- Develop a strong understanding of Central Monitoring RBQM systems and tools to stand out in the application process
- Highlight your experience with data analysis and interpretation, including proficiency in Excel and other software
- Be prepared to discuss your experience with risk management and quality assurance in clinical trials
- Showcase your ability to work collaboratively with cross-functional teams and communicate complex data insights effectively
- Consider obtaining certification in clinical trial management or a related field to demonstrate your expertise
- Research Parexel's values and mission to understand the company culture and demonstrate your alignment with their goals
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