Central Monitor

Roles & Responsibilities
• Execute centralized monitoring activities across assigned clinical trials
• Perform ongoing data surveillance to identify trends, anomalies, and risk signals
• Review outputs from central monitoring tools in collaboration with Data Analysts
• Ensure compliance with RBQM/RBM plans, SOPs, and GCP requirements
• Identify site-level and study-level risks in line with IQRMP
• Support risk assessment, root cause analysis, and CAPA recommendations
• Design, review, and optimize Key Risk Indicators (KRIs) and thresholds
• Monitor and manage Quality Tolerance Limits (QTLs)
• Act as central monitoring point of contact for assigned studies
• Collaborate with RSLs, Study Leaders, Data Managers, and Clinical Scientists
• Participate in Clinical Trial Team (CTT) meetings with data-driven insights
• Develop, maintain, and review Trial Monitoring Plans (TMPs)
• Document findings, escalate critical risks, and ensure inspection readiness
• Support continuous improvement initiatives in centralized monitoring processes

Qualification
• University degree in Life Sciences, Business, Operations, or related discipline

Experience
• Minimum 5 years of experience in pharmaceutical industry or CROs
• At least 3 years of hands-on experience in clinical monitoring (central or site-based)

Skills
• Strong expertise in central monitoring, KRIs, and RBQM strategies
• Good understanding of adaptive monitoring models and risk management
• In-depth knowledge of GCP, ICH guidelines, and clinical trial processes
• Experience with clinical data analytics or data management is an advantage
• Strong analytical, critical thinking, and problem-solving skills
• Excellent written and verbal communication skills
• Proficient in documentation and inspection-ready practices

About the Organization
Novartis is a global healthcare company focused on reimagining medicine to improve and extend people’s lives. Through innovative science, advanced technologies, and a strong commitment to quality, Novartis delivers breakthrough therapies and supports high standards in clinical research worldwide.