Monitoring Oversight & Quality
• Oversee clinical monitoring activities across assigned studies, ensuring compliance with protocols, SOPs, ICH-GCP, and regulatory requirements.
• Review monitoring plans, key monitoring outputs, and issue escalations, ensuring timely resolution of critical findings.
• Provide oversight of CRO and internal monitoring performance, ensuring consistency and quality across studies.
• Support co-monitoring visits, monitoring assessments, and quality reviews as required.
KPI & Performance Management
• Develop and maintain monitoring KPIs and performance dashboards.
• Analyze trends, identify risk signals, and drive corrective and preventive actions.
• Provide regular performance and compliance reporting to senior leadership.
• Regulatory Compliance & Inspection Readiness
• Ensure compliance with FDA, EMA, ICH-GCP, and other applicable global regulations.
• Monitor regulatory changes and implement updates to processes, training, and oversight practices.
• Serve as a monitoring SME during audits and regulatory inspections.
• Support inspection readiness, CAPA management, and remediation activities.
Process Excellence
• Lead initiatives to improve monitoring processes, tools, and technologies.
• Champion risk-based and centralized monitoring strategies.
• Drive standardization of monitoring documentation, templates, and best practices.
• Leverage analytics and automation to enhance oversight and reporting efficiency.
Leadership & Collaboration
• Partner with cross-functional teams to ensure effective study execution and quality oversight.
• Mentor and develop monitoring staff and provide guidance on performance expectations and compliance standards.
• Present monitoring insights and risk assessments to study teams and governance forums.
• Support CRO/vendor selection, governance, and performance management.
• Proactively identify and mitigate risks related to site performance, protocol compliance, and data integrity.
Experience:
• 15+ year
📌 Principal Scientist (Pune)
🏢 LUPIN
📍 Pune