Risk and Central Monitoring Associate Manager

🔥 3 minutes ago

🌐 United Kingdom, Serbia, +1 more countries – Remote

🇬🇧 United Kingdom – Remote 🇷🇸 Serbia – Remote 🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🎲 Risk

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👻 Ghost score 10%

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• 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

• 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

• 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