06 nov
|
Premier Research
|
Valladolid
06 nov
Premier Research
Valladolid
OverviewAs 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.
ResponsabilidadesServe 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 principales5+ 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 (Valladolid)
🏢 Premier Research
📍 Valladolid