Monitoring Oversight & Quality /n /n

- 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.

/n /n KPI & Performance Management /n /n

- 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.

/n /n Process Excellence /n /n

- 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.

/n /n Leadership & Collaboration /n /n

- 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 identify and mitigate risks related to site performance, protocol compliance, and data integrity.

/n /n Experience: /n /n

- 15+ years of clinical research or clinical operations experience, including significant monitoring experience.

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- 3+ years of leadership, management, or oversight experience.

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- Experience with RBM and clinical technology platforms and dashboards

/n /n Key Competencies /n /n

- Deep understanding of GCP, global regulatory(FDA, EMA) requirements, and inspection readiness.

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- Strong analytical skills with experience developing KPIs and dashboards.

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- Excellent leadership, communication, and stakeholder management abilities.

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- Proven ability to manage multiple studies and priorities in a quick-paced environment.

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- Proficiency with CTMS, eTMF, and data visualization tools.

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📌 Principal Scientist (Pune)
🏢 LUPIN
📍 Pune