Manager, Central Monitoring

Parexel

. Participate in developing and refining the Study Quality Risk Assessment and Control Tracker to identify and manage study risks .

Posted 10/30/2026full-timeRemote • Poland, SerbiaSeniorLead💰 PLN 300,000 - PLN 320,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Central Monitoring and Risk-Based Quality Management (RBQM) methodologies, with strong analytical skills to assess study risks and trends. Proficient in data analysis and communication, effectively collaborating with cross-functional teams to enhance clinical study outcomes.

Highest-signal resume keywords

Central Monitoring ExperienceRisk-Based Quality Management (RBQM)Data Analysis Tools ProficiencyClinical Drug Development KnowledgeMicrosoft Excel Advanced Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data AnalysisStatistical MethodologiesQuality Control ProcessesTroubleshooting Analytical SystemsCentral Monitoring Plan DevelopmentKRI/KPI InterpretationRoot Cause AnalysisClinical Database KnowledgeElectronic Data Capture SystemsRegulatory Requirements Knowledge

Soft Skills

Analytical Problem-SolvingCritical ThinkingEffective CommunicationInterpersonal SkillsRelationship Building

Tools & Technologies

CluePointsMicrosoft OfficeData Manipulation ToolsCentral Monitoring RBQM System

Certifications & Qualifications

Ph.D.PharmDMDBoard Certified MD

Industry Keywords

BiotechnologyPharmaceutical IndustryICH GuidelinesGCP GuidelinesClinical TrialsAuditing Procedures

About the role

Key responsibilities & impact

Participate in developing and refining the Study Quality Risk Assessment and Control Tracker to identify and manage study risks
Lead creation of the Central Monitoring Plan aligned with study-specific needs and RBQM methodologies
Configure, implement, and execute the Central Monitoring RBQM system across assigned studies with data analysts
Conduct study-level Central Monitoring Reviews using data analysis tools
Interpret KRIs/KPIs and assess trends to identify areas requiring intervention
Present findings to clinical study teams and support root cause analysis
Provide recommendations for follow-up actions addressing identified risks
Document Central Monitoring Review outputs and track decisions and action closure
Act as Central Monitoring subject matter expert during audits, inspections, and within study teams
Partner with outsourcing management to oversee CRO Central Monitoring activities
Evaluate processes and recommend improvements to tools, metrics, and methodologies
Represent Central Monitoring in cross-functional process improvement initiatives
Assess emerging technologies to enhance Central Monitoring capabilities
Support several studies within a therapeutic area and at program level
Collaborate with Central Monitors and Centralized Data Risk Analysts

Requirements

What you’ll need

High School Diploma, Associates Degree, Bachelors Degree, Masters Degree, Ph.D., PharmD, MD, or Board Certified MD
At least 7 years of relevant experience in the biotechnology/pharmaceutical industry
Minimum of 1 year of direct Central Monitoring experience
Strong analytical problem-solving and critical thinking abilities
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
Ability to identify and interpret current and future business trends and apply them to centralized monitoring practices
Excellent written communication skills
Aptitude for mathematical concepts, statistical methodologies, and data analytics
Knowledge and experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures
Proficiency in Microsoft Office applications, with advanced Excel skills for data manipulation and reporting
Experience using CluePoints is preferred

Benefits

Comp & perks

Premium salary
Attractive benefits
Medical care plan: Health, Dental & Vision
Life Assurance
Excellent work environment
Culture of teamwork and collaboration
People who motivate and face challenges together
Innovative technology
Excellent training
Annual performance-based bonus plan for eligible roles
Annual salary review for eligible roles
Total rewards incentives for eligible roles
Flexible work arrangements
Professional development
Up to 25% travel requirement