Job DescriptionMonitoring Oversight & Quality Nn 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. NnKPI & Performance Management Nn 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. NnProcess Excellence Nn Lead initiatives to improve monitoring processes, tools, and technologies. N Champion risk-based andcentralized monitoring strategies. N Drive standardization of monitoring documentation, templates, and best practices.



N Leverage analytics and automation to enhance oversight and reporting efficiency. NnLeadership& Collaboration Nn 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 identify and mitigate risks related to site performance, protocol compliance, and data integrity. NnnExperience: Nn 15+ years of clinical research or clinical operations experience, including significant monitoring experience. N 3+ years of leadership,management, or oversight experience. N Experience with RBM andclinical technology platforms and dashboards NnnKey Competencies Nn Deep understanding of GCP, global regulatory(FDA, EMA) requirements, and inspection readiness. N Solid analytical skills with experience developing KPIs and dashboards. N Excellent leadership, communication, and stakeholder management abilities. N Proven ability to manage multiple studies and priorities in a fast-paced environment. N Proficiency with CTMS, eTMF, and data visualization tools. N

📌 Principal Scientist (Dhowara)
🏢 LUPIN
📍 Dhowara