Risk and Central Monitoring Associate Manager

Worldwide Clinical Trials

. Lead and oversee RBQM activities for assigned clinical trials, ensuring alignment with study objectives and regulatory expectations .

Posted 10/15/2026full-timeRemote • United Kingdom, Serbia, SpainMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Risk-Based Quality Management (RBQM) and central monitoring strategies, with a strong focus on risk assessment methodologies and regulatory compliance. Proven ability to analyze complex data and provide actionable insights to support clinical trial execution and inspection readiness.

Highest-signal resume keywords

Risk-Based Quality Management (RBQM)Central MonitoringRisk Assessment MethodologiesData AnalysisRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ExperienceRisk AssessmentTrend AnalysisMonitoring StrategiesUser Acceptance Testing

Soft Skills

Critical ThinkingProblem-SolvingCommunicationOrganizational SkillsPresentation Skills

Tools & Technologies

RBQM ToolsCentral Monitoring SolutionsMicrosoft Office

Certifications & Qualifications

BScRegistered Nurse Qualification

Industry Keywords

ICH GuidelinesKey Risk Indicators (KRIs)Quality Tolerance Limits (QTLs)Study OversightInspection Readiness

About the role

Key responsibilities & impact

Lead and oversee RBQM activities for assigned clinical trials, ensuring alignment with study objectives and regulatory expectations
Develop and maintain Central Monitoring Plans, securing required approvals and supporting effective study oversight
Coordinate cross-functional risk assessments and facilitate the identification of key study risks, KRIs and QTLs where applicable
Support study teams through training and guidance on RBQM strategies, central monitoring approaches and risk management processes
Perform central monitoring reviews, analysing trends, outliers and risk signals to identify potential issues and recommend actions
Contribute to the development and maintenance of study-level monitoring strategies that support quality-focused trial execution
Ensure inspection readiness by maintaining high-quality risk management and central monitoring documentation
Support technology-related activities, including user acceptance testing of RBQM tools and central monitoring solutions
Participate in sponsor meetings, bid defence activities, audits and other stakeholder engagements as required

Requirements

What you’ll need

BSc, Registered Nurse qualification, or an equivalent combination of education, skills and experience
At least 4 years of clinical research experience, including a minimum of 3 years of experience in Risk-Based Monitoring and relevant ICH/regulatory guidance
Previous experience working as a Central Monitor or within a central monitoring function
Strong understanding of RBQM principles, risk assessment methodologies, KRIs, QTLs and study monitoring strategies
Ability to analyse complex data, identify trends and outliers, and translate findings into meaningful risk insights and recommendations
Demonstrated critical thinking and problem-solving skills, with the ability to assess issues and determine appropriate solutions
Proven ability to work effectively across functions and within global, cross-cultural teams to achieve project milestones
Proficiency in English
Strong communication, presentation, organisational and Microsoft Office skills

Benefits

Comp & perks

Equal employment opportunities regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law