Clinical Lead II - Rare Diseases / Oncology

premierresearch; España; On-site; EUR 90,000 - 120,000; Full time

Job summary

Premier Research is seeking a Clinical Lead II for Rare Diseases / Oncology to join the Clinical Management team in Spain. You will help biotech, medtech, and specialty pharma partners transform ideas into medicines and diagnostics, while growing your skills and balancing life requirements.

You will help deliver clinical trial oversight, site management quality, and sponsor communications, with a focus on RBM, dashboards, and audit readiness across global trials.

Qualifications

• Bachelor's degree in a clinical, biological, scientific, or health-related field (or equivalent).
• At least 2 years as Clinical Lead in a CRO with onsite monitoring experience, RBM preferred.
• Experience in Rare Diseases and Oncology is required.
• Clinical Lead experience managing trials rather than solely CRA work.
• Experience in biliary liver disease and Oncology (CAR-T or Cell Gene Therapy) and pediatric trials is a plus.
• Knowledge of clinical financials, budgets, pass-through and resource management.

Responsibilities

• Serves as initial contact for site management and monitoring quality concerns, including sPIPs.
• Plans, presents and participates in sponsor calls, giving status updates on deliverables.
• Oversees quality of monitoring and site management through dashboards and reporting.
• Contributes to central monitoring plan and monitors data entry timelines and action items.
• Ensures audit readiness for Premier and sites; responds to audit findings and remediation.
• Escalates quality or data events through established channels as needed.

Skills

Clinical monitoring

Sponsor calls

Quality oversight

Audit readiness

Risk-Based Monitoring

Education

Bachelor's degree in clinical/biological/science

Tools

Dashboards/reporting tools

Job description

Premier Research is looking for 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 and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

Your ideas influence the way we work, and your voice matters here.

As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You'll Be Doing:

• Serves as initial point of contact for all 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 by providing status updates on clinical deliverables.
• Oversees the quality of clinical monitoring, central monitoring and site management deliverables through the use of dashboards/reporting tools.
• Strong contributor to the central monitoring plan.
• Monitors clinical operations metrics, activities and timelines on a regular basis; Tracks data entry timelines, open actions, protocol deviations, queries aging reports, SDR/SDV backlog and monitoring visit report turnaround timelines.
• Ensures a state of audit readiness for both Premier and sites.
• Reviews/responds to audit findings and support sites in remediation/responses to any site audit findings.
• Escalates through the established channels CRA/CM/SSU performance concerns, quality events, data breaches, serious breaches, scientific misconduct or any other event that requires prompt assessment and reporting.

What We Are Searching For:

• Bachelor's degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience.
• At least 2 years of experience as a Clinical Lead (ideally global) gained in a CRO setting and must have prior onsite monitoring experience, ideally to include Risk-Based Monitoring.
• Must have prior experience in both Rare Diseases and Oncology.
• This will ideally have been gained as a Clinical Lead managing trials vs solely in a CRA capacity.
• Biliary liver disease therapeutic experience, Oncology experience in CAR-T and / or Cell Gene Therapy in addition to experience working on pediatric trials will be the optimum.
• Working knowledge of clinical financials including understanding of budgets, pass- through and resource management