Job Description

Monitoring Oversight & Quality

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

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Develop and maintain monitoring KPIs and performance dashboards.
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Analyze trends, identify risk signals, and drive corrective and preventive actions.
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Provide regular performance and compliance reporting to senior leadership.
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Regulatory Compliance & Inspection Readiness
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Ensure compliance with FDA, EMA, ICH-GCP, and other applicable global regulations.
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Monitor regulatory changes and implement updates to processes, training, and oversight practices.
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Serve as a monitoring SME during audits and regulatory inspections.
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Support inspection readiness, CAPA management, and remediation activities.
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Process Excellence

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

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

📌 Principal Scientist Pune
🏢 LUPIN
📍 Pune