Job DescriptionMonitoring Oversight & Quality
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- Oversee clinical monitoring activities across assigned studies, ensuring compliance with protocols, SOPs, ICH-GCP, and regulatory requirements.n
- Review monitoring plans, key monitoring outputs, and issue escalations, ensuring timely resolution of critical findings.n
- Provide oversight of CRO and internal monitoring performance, ensuring consistency and quality across studies.n
- Support co-monitoring visits, monitoring assessments, and quality reviews as required.n

nKPI & Performance Management
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- Develop and maintain monitoring KPIs and performance dashboards.n
- Analyze trends, identify risk signals, and drive corrective and preventive actions.n
- Provide regular performance and compliance reporting to senior leadership.n
- Regulatory Compliance & Inspection Readinessn
- Ensure compliance with FDA, EMA, ICH-GCP, and other applicable global regulations.n
- Monitor regulatory changes and implement updates to processes, training, and oversight practices.n




- Serve as a monitoring SME during audits and regulatory inspections.n
- Support inspection readiness, CAPA management, and remediation activities.n

nProcess Excellence
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- Lead initiatives to improve monitoring processes, tools, and technologies.n
- Champion risk-based and centralized monitoring strategies.n
- Drive standardization of monitoring documentation, templates, and best practices.n
- Leverage analytics and automation to enhance oversight and reporting efficiency.n

nLeadership & Collaboration
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- Partner with cross-functional teams to ensure effective study execution and quality oversight.n
- Mentor and develop monitoring staff and provide guidance on performance expectations and compliance standards.n
- Present monitoring insights and risk assessments to study teams and governance forums.n
- Support CRO/vendor selection, governance, and performance management.n
- Proactively identify and mitigate risks

📌 Principal Scientist (Pune)
🏢 LUPIN
📍 Pune