Clinical Lead II: Rare Diseases & Oncology – Global Impact

46 Premier Research Group SL; España; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

Premier Research is seeking a Clinical Lead II - Rare Diseases / Oncology to join our Clinical Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas into new medicines, devices, and diagnostics.

We are committed to growth, skills development, and work-life balance, supporting your voice and growth within a collaborative culture. You will oversee site management and monitoring quality, manage sponsor communications and dashboards, and help

Qualifications

• Bachelor’s degree in a clinical, biological, scientific, or health-related field or equivalent work experience.
• At least 2 years of experience as a Clinical Lead in a CRO setting with onsite monitoring experience, ideally including Risk-Based Monitoring.
• Must have experience in both Rare Diseases and Oncology.
• Ideally gained as a Clinical Lead managing trials rather than solely as a CRA.
• Experience in biliary liver disease, Oncology (CAR-T / Cell Gene Therapy), and pediatric trials is a plus.
• Knowledge of clinical financials including budgets, pass-throughs and resource management.

Responsabilités

• Serves as initial point of contact for site management and monitoring quality concerns, including initiation and oversight of site performance improvement plans (sPIP).
• Plans, presents and participates in sponsor calls, representing Clinical and SSU function with status updates on clinical deliverables.
• Oversees the quality of clinical monitoring, central monitoring and site management deliverables through dashboards/reporting tools.
• Contributes to the central monitoring plan.
• Monitors clinical operations metrics, timelines, data entry, actions, protocol deviations, queries aging, SDR/SDV backlog and monitoring visit report turnaround.
• Ensures audit readiness for Premier and sites; reviews/responds to audit findings; supports remediation.

Connaissances

Clinical Lead experience

Onsite monitoring

Risk-Based Monitoring

Global CRO experience

Budgeting / financials

Formation

Bachelor’s degree or international equivalent

Description du poste

Premier Research is seeking a Clinical Lead II - Rare Diseases / Oncology to join our Clinical Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas into new medicines, devices, and diagnostics.

We are committed to growth, skills development, and work-life balance, supporting your voice and growth within a collaborative culture. You will oversee site management and monitoring quality, manage sponsor communications and dashboards, and help