Job Summary:The Risk-Based Monitoring (RBM) System Manager is responsible for overseeing the implementation, maintenance, and optimization of risk-based monitoring processes and systems within clinical trials. This role ensures compliance with regulatory guidelines while enhancing data quality, patient safety, and operational efficiency through proactive risk assessment and mitigation strategies.Key Responsibilities:1. RBM System Implementation & Management:• Lead the design, implementation, and management of RBM systems and tools.• Ensure integration of RBM methodologies with existing clinical trial management systems (CTMS), electronic data capture (EDC), and other platforms.• Define and maintain RBM system configurations and thresholds for risk detection.2. Risk Assessment & Monitoring:• Develop risk assessment frameworks to identify critical data and processes in clinical trials.• Analyze clinical and operational data to detect potential risks and trigger mitigation actions.• Monitor Key Risk Indicators (KRIs) and provide actionable insights to study teams.3. Compliance & Regulatory Alignment:• Ensure RBM strategies align with ICH-GCP, FDA, EMA, and other regulatory requirements.• Support audits and inspections related to risk-based monitoring activities.• Maintain documentation and processes for regulatory compliance.4. Cross-functional Collaboration & Training:• Work closely with clinical operations, data management, biostatistics, and IT teams to align RBM strategies.• Provide training and guidance to stakeholders on RBM principles and system functionalities.• Support study teams in implementing risk-based approaches to site monitoring.5. Process Improvement & Innovation:• Continuously evaluate RBM tools and processes for efficiency and effectiveness.• Implement best practices and innovations in risk-based monitoring methodologies.• Drive automation and data-driven decision-making in clinical trial oversight.Qualifications & Experience:Education:• Bachelor’s or Master’s degree in Life Sciences, Healthcare, Data Science, or a related field.Experience:• 5+ years of experience in clinical trials, risk-based monitoring, or clinical operations in a Biotechnology or Pharmaceutical company.• Experience with RBM tools, CTMS, EDC, and other clinical trial technologies.• 5+ years of experience with CluePoint tool and Key Result Indicators (KRI).• Experience in multiple Therapeutic Areas.• Knowledge of ICH-GCP and global regulatory requirements for clinical trials.Skills & Competencies:• Strong analytical skills with experience in data-driven risk assessment.• Expertise in clinical trial monitoring methodologies.• Proficiency in RBM software, data visualization, and reporting tools.• Excellent communication and cross-functional collaboration skills.• Problem-solving mindset with a focus on innovation and efficiency.Preferred Qualifications:• Experience with AI-driven RBM technologies.• Certification in clinical research (e.g., ACRP, SOCRA) is a plus.
Job Title
Risk-Based Monitoring (RBM) System Manager