Clinical Lead II – Dermatology

Overview

As Clinical Lead II, you drive site management and monitoring quality to enable safe, effective dermatology studies. You’ll act as the main contact for site performance and sponsor communications, ensuring timely deliverables and audit readiness. You’ll guide monitoring quality and central monitoring efforts, shaping risk-based monitoring and remediation. This role offers a meaningful impact on patient outcomes within a collaborative Clinical Management team.

Responsibilities

• Serve as initial point of contact for site management and monitoring quality concerns, initiating and overseeing site performance improvement plans (sPIP)
• Plan, present, and participate in sponsor calls, providing status updates on clinical deliverables
• Oversee quality of monitoring, central monitoring, and site deliverables via dashboards and reporting tools
• Monitor clinical operations metrics, timelines, data entry, deviations, queries, SDR/SDV backlog, and monitoring report turnaround
• Ensure audit readiness for Premier and sites; review/respond to audit findings; support remediation
• Escalate performance concerns, quality events, data breaches, serious breaches, or misconduct through established channels
• Oversight of CRA performance, monitoring quality, and site management activities
• Experience tracking key metrics (enrolment, protocol deviations, SDV/SDR completion, timeliness) and site action plans
• Manage study risks, escalations, quality events, and compliance issues
• Understand study budgets, forecasting, and resource management

Key requirements

• 5+ years in clinical research within a CRO, sponsor, or clinical operations environment
• Prior experience as Clinical Lead, Lead CRA, Senior CRA, CTM, or equivalent
• Strong understanding of RBM, centralized monitoring, visit oversight, and issue escalation processes
• Dermatology experience preferred, ideally Phase II-III studies
• Onsite monitoring experience preferred
• Experience overseeing CRA performance and site management activities
• Audit and inspection readiness experience including CAPA management
• Knowledge of study budgets, forecasting, and resource management

• strong communication and sponsorship-facing skills
• leadership and mentorship
• problem-solving and proactive escalation
• Risk-Based Monitoring (RBM)
• centralized monitoring
• dashboard/reporting tools

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