Monitoring Oversight & Quality

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- 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.
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nKPI & Performance Management

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- 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.
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nProcess Excellence

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- 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.
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nLeadership & Collaboration

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- 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.
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nExperience:

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- 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
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nKey Competencies

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- 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