Risk and Central Monitoring Associate Manager

🔥 12 hours ago

🌐 United States, Brazil, +2 more countries – Remote

🇺🇸 United States – Remote 🇧🇷 Brazil – Remote 🇨🇦 Canada – Remote 🇲🇽 Mexico – Remote

🏄 California, Florida, +4 more states – Remote

🏄 California – Remote 🐊 Florida – Remote 🌽 Illinois – Remote 🌲 North Carolina – Remote ❄️ Minnesota – Remote 🎸 Tennessee – Remote

💵 $65.5k - $130.5k / year

⏰ Full Time

🟡 Mid-level

🎲 Risk

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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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 Risk-Based Quality Management (RBQM) activities for assigned clinical studies • Develop and maintain Central Monitoring Plans, ensuring appropriate approvals and alignment with study strategies • Support creation and ongoing review of study risk assessments with cross-functional teams • Facilitate identification, tracking, and monitoring of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) • Perform centralized monitoring reviews to identify trends, outliers, signals, and potential risks, recommending actions to study teams • Maintain central monitoring dashboards and support ongoing monitoring throughout the study lifecycle • Deliver training and guidance to study teams on RBQM strategies, monitoring approaches, and risk management processes • Contribute to inspection readiness, budget awareness, sponsor interactions, audits, and project-related meetings • Collaborate with global teams and internal stakeholders and sponsors to support inspection-ready processes and clinical trial quality

🎯 Requirements

• BSc, RN, or an equivalent combination of education, skills, and experience • At least 4 years of clinical research experience • Minimum of 3 years of experience with Risk-Based Monitoring (RBM) and associated ICH/regulatory guidance • Prior experience working as a Central Monitor or within a Central Monitoring function • Strong understanding of RBQM principles, study risk assessments, centralized monitoring, KRIs, and QTLs • Ability to analyze complex data, identify trends and risks, and apply critical thinking to problem-solving and issue resolution • Experience collaborating across functions and working effectively within global project teams • Strong communication, presentation, planning, and organizational skills • Proficiency in English • Strong proficiency with Microsoft Office and clinical technology systems

🏖️ Benefits

• Competitive benefits package depending on location • Inclusive and equitable workplace • Transparent compensation and pay equity