Manager, Central Monitoring
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Job Description
Central Monitoring Manager supporting Parexel’s global clinical trials in Argentina. Reviewing clinical risk data, guiding study teams, and improving RBQM processes.
Responsibilities:
- Participate in the development and refinement of the Study Quality Risk Assessment and Control Tracker (QRACT) to identify and manage study risks
- Lead the creation of Central Monitoring Plans aligned with study-specific needs and Risk Based Quality Management methodologies
- Work with data analysts to configure, implement, and execute the Central Monitoring RBQM system across assigned studies
- Conduct study-level Central Monitoring Reviews using data analysis tools
- Interpret KRIs/KPIs and assess data trends to identify areas requiring intervention
- Present findings to clinical study teams, support root cause analysis, and provide recommendations for follow-up actions
- Document Central Monitoring Review meeting outputs, track decisions, and ensure timely closure of actions
- Act as a Central Monitoring subject matter expert during audits, inspections, and within study teams
- Partner with outsourcing management to align monitoring strategies and oversee CRO execution of Central Monitoring activities
- Evaluate Central Monitoring processes and recommend improvements to tools, metrics, and methodologies
- Represent Central Monitoring in cross-functional process improvement initiatives and assess emerging technologies
Requirements:
- 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; ability to 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 KRIs and 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
- Experience using CluePoints or similar centralized monitoring system preferred
- High School Diploma, Associates Degree, Bachelors Degree, Masters Degree, Ph.D., PharmD, MD, or Board Certified MD listed as minimal educational requirements
- At least 7 years of relevant experience in the biotechnology/pharmaceutical industry
- Minimum 1 year of direct Central Monitoring experience
- Site monitoring or data management experience is a plus
Benefits:
- No benefits, perks, or compensation extras are specified in the posting.
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