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+ 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

Key Competencies

- 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 rapid-paced environment.
- Proficiency with CTMS, eTMF, and data visualization tools.

📌 Principal Scientist (Pune)
🏢 LUPIN
📍 Pune