Principal scientist

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 fast-paced environment. Proficiency with CTMS, e TMF, and data visualization tools.