Risk and Central Monitoring Associate Manager

This is a fully remote position, open to applicants in United Kingdom, +2 more countries.

📋 Description

• Lead and manage Risk-Based Quality Management (RBQM) initiatives for designated clinical trials, ensuring they align with study goals and regulatory standards.

• Create and uphold Central Monitoring Plans, obtaining necessary approvals and facilitating effective oversight of studies.

• Organize cross-functional risk evaluations and aid in identifying critical study risks, Key Risk Indicators (KRIs), and Quality Tolerance Limits (QTLs) as applicable.

• Assist study teams by providing training and guidance on RBQM methodologies, central monitoring techniques, and risk management protocols.

• Conduct central monitoring evaluations, analyzing trends, anomalies, and risk indicators to pinpoint potential issues and suggest corrective measures.

• Contribute to the formulation and upkeep of study-specific monitoring strategies that enhance quality-driven trial execution.

• Maintain inspection readiness by ensuring high-caliber documentation for risk management and central monitoring.

• Support technology-related initiatives, including user acceptance testing of RBQM tools and central monitoring systems.

• Engage in sponsor meetings, bid defense processes, audits, and other necessary stakeholder interactions.

⛳️ Requirements

• Bachelor of Science, Registered Nurse certification, or an equivalent combination of education, skills, and experience.

• Minimum of 4 years of experience in clinical research, including at least 3 years in Risk-Based Monitoring with relevant ICH/regulatory guidance.

• Prior experience in a Central Monitoring role or within a central monitoring team.

• Solid understanding of RBQM principles, risk assessment methodologies, KRIs, QTLs, and study monitoring frameworks.

• Capability to analyze intricate data, recognize trends and anomalies, and convert findings into actionable risk insights and recommendations.

• Demonstrated critical thinking and problem-solving abilities, with the capacity to evaluate issues and determine suitable solutions.

• Proven track record of effective collaboration across functions and within global, cross-cultural teams to meet project objectives.

• Proficient in English.

• Strong skills in communication, presentation, organization, and Microsoft Office applications.

🏝️ Benefits

• Equal employment opportunities irrespective 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 any other class protected by applicable law.