[Hiring] Manager, Central Monitoring @Parexel

Role Description

The Manager, Central Monitoring is accountable for centralized monitoring activities for global and/or complex trials, analytical data review of key risk and/or operational performance data and presenting as an integral member of the Clinical Study team for clinical development studies.

• Collaborate on Study Quality Risk Assessment: Participate 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: Lead the creation of the Central Monitoring Plan, ensuring alignment with study-specific needs and Risk Based Quality Management (RBQM) methodologies.
• Oversee Central Monitoring Execution: Work 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: Conduct study-level Central Monitoring Reviews using data analysis tools, interpret KRIs/KPIs, and assess trends to identify areas requiring intervention.
• Facilitate Study Team Decisions: Present findings to clinical study teams, support root cause analysis, and provide recommendations for follow-up actions to address identified risks.
• Document and Track Actions: Document outputs from Central Monitoring Review meetings, track decisions, and ensure timely closure of actions.
• Act as Central Monitoring subject matter expert: Represent Central Monitoring as a subject matter expert during audits, inspections, and within study teams on client processes.
• Provide Oversight of Contract Research Organization (CRO) Activities: Partner with outsourcing management to align monitoring strategies and ensure CRO partners execute Central Monitoring activities according to the agreed standards.
• Drive Process Improvements: Evaluate the effectiveness of Central Monitoring processes, identify areas for improvement, and recommend enhancements to tools, metrics, and methodologies.
• Represent Central Monitoring in Initiatives: Represent the function in cross-functional process improvement initiatives and assess emerging technologies to enhance Central Monitoring capabilities.

Qualifications

• Strong analytical problem-solving and critical thinking abilities.
• 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.
• Preferred: Experience using CluePoints or similar centralized monitoring system.

Requirements

• High School Diploma
• Associates Degree
• Bachelors Degree
• Masters Degree
• Ph.D.
• PharmD
• MD
• Board Certified MD
• At least 7 years of relevant experience in the biotechnology/pharmaceutical industry, with a minimum of 1 year with direct Central Monitoring experience.
• Site monitoring or data management experience a plus.