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

📌 Senior Clinical Operations Oversight Specialist (India)
🏢 LUPIN
📍 India