Job Description
Monitoring Oversight & Quality
/n
/n
- 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
/n
KPI & Performance Management
/n
/n
- 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 Readiness
/n
- 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
/n
Process Excellence
/n
/n
- 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
/n
Leadership & Collaboration
/n
/n
- 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
📌 Principal Scientist (Pune)
🏢 LUPIN
📍 Pune