Overview

As Clinical Lead II in Dermatology, you will guide site management and monitoring quality to support clinical deliverables. You will engage with sponsors, oversee monitoring quality, and maintain audit readiness across Premier and sites. Your role centers on RBM and centralized monitoring to drive timely delivery and issue resolution. You join a mission-driven team focused on delivering impactful medical innovations for patients.

Responsabilidades

- Serve as initial point of contact for site management and monitoring quality concerns, initiating improvement plans
- Plan and present sponsor updates on clinical deliverables across the Clinical and SSU functions
- Oversee monitoring quality and site management via dashboards and reporting tools; contribute to central monitoring plan
- Monitor operations metrics, data entry timelines, protocol deviations, and backlog; track action timeliness
- Maintain audit readiness; respond to audit findings and support remediation at sites
- Escalate performance concerns and quality events through established channels
- Support risk-based monitoring and visit oversight to ensure compliant study execution




- Manage study deliverables and oversee CRA performance and monitoring quality

Requisitos principales

- 5+ years of clinical research experience in 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
- Dermatology experience preferred, especially Phase II-III dermatology studies; onsite monitoring preferred
- Experience tracking enrolment, protocol deviations, queries, SDV/SDR, monitoring timeliness, and site action plans
- Audit and inspection readiness experience, including CAPA and remediation support
- Experience managing study risks, escalations, quality events, and compliance issues
- Working knowledge of study budgets, forecasting, and resource management

- Excellent written and verbal communication
- Cross-functional collaboration and stakeholder management
- Analytical thinking and attention to detail
- Risk-Based Monitoring (RBM)
- Centralized monitoring
- Sponsorship and site management dashboards

📌 Clinical Lead II - Dermatology (España)
🏢 Premier Research
📍 España