Principal Scientist

Lupin; Pune District; On-site; INR 4,000,000 - 9,000,000; Full time

Job summary

Lupin is seeking an experienced Monitoring Lead to oversee global clinical monitoring across studies, ensuring adherence to ICH-GCP and regulatory standards. The role emphasizes RBM implementation, KPI development, and risk management within a matrix-driven environment.

The position requires deep regulatory knowledge, strong analytics, and collaboration with CROs and internal teams to maintain inspection readiness and data integrity. Mumbai/Pune locations may apply.

Qualifications

• 15+ years of clinical research or clinical operations experience including monitoring
• 3+ years of leadership or oversight experience
• Experience with RBM and clinical technology platforms
• Deep understanding of GCP, FDA, EMA and inspection readiness
• Strong analytical skills and KPI/dashboard development
• Excellent leadership and stakeholder management
• Ability to manage multiple studies in a fast-paced environment
• Proficiency with CTMS, eTMF, and data visualization tools

Responsibilities

• Oversee monitoring activities across assigned studies, ensuring compliance with protocols, SOPs, ICH-GCP, and regulatory requirements
• Review monitoring plans, 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
• Develop and maintain monitoring KPIs and performance dashboards
• Analyze trends, identify risk signals, and drive CAPA actions
• Provide regular performance and compliance reporting to senior leadership
• Regulatory Compliance & Inspection Readiness: Ensure compliance with FDA, EMA, ICH-GCP, and global regulations
• Monitor regulatory changes and implement updates to processes, training, and oversight practices
• Serve as 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
• 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

Job description

• 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.
• 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+ years of clinical research or clinical operations experience, including significant monitoring experience.
• 3+ years of leadership, management, or oversight experience.
• Experience with RBM and clinical technology platforms and dashboards
• Deep understanding of GCP, global regulatory(FDA, EMA) requirements, and inspection readiness.
• Strong analytical skills with experience developing KPIs and dashboards.
• Excellent leadership, communication, and stakeholder management abilities.
• Proven ability to manage multiple studies and priorities in a fast-paced environment.
• Proficiency with CTMS, eTMF, and data visualization tools.