Central Monitoring, Manager

The Manager, Central Monitoring at Parexel is responsible for centralized monitoring activities for global and complex clinical trials, including data review, risk assessment, and collaboration with study teams to ensure quality and compliance.

Location: United States

Responsibilities

• Participate in the development and refinement of the Study Quality Risk Assessment and Control Tracker (QRACT).
• Lead the creation of the Central Monitoring Plan, ensuring alignment with study-specific needs and RBQM methodologies.
• Work with data analysts to configure, implement, and execute the Central Monitoring RBQM system.
• Conduct study-level Central Monitoring Reviews using data analysis tools, interpret KRIs/KPIs, and assess trends.
• Present findings to clinical study teams, support root cause analysis, and provide recommendations.
• Document outputs from Central Monitoring Review meetings, track decisions, and ensure timely closure of actions.
• Act as Central Monitoring subject matter expert during audits, inspections, and within study teams.
• Partner with outsourcing management to align monitoring strategies and ensure CRO compliance.
• Evaluate the effectiveness of Central Monitoring processes and recommend improvements.
• Represent the function in cross-functional initiatives and assess emerging technologies.

Requirements

• At least 1 year of direct Central Monitoring experience.
• Strong analytical problem-solving and critical thinking abilities.
• Working knowledge of the clinical drug development process, including ICH, GCP, and regulatory requirements.
• Effective communication and interpersonal skills.
• Ability to interpret current and future business trends and apply them to monitoring practices.
• Excellent written communication skills.
• Aptitude for mathematical concepts, statistical methodologies, and data analytics.
• Knowledge of clinical databases, electronic data capture systems, quality control, and auditing procedures.
• Proficiency in Microsoft Office, especially Excel.
• Preferred: Experience with CluePoints or similar RBQM systems.

Additional Information

• Requires up to 25% travel.