Clinical Lead II - Rare Diseases / Oncology

premierresearch; Polska; On-site; PLN 226,000 - 276,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Retirement plan

Paid time off

Employee Assistance Program

Job summary

Premier Research is seeking a Clinical Lead II specializing in Rare Diseases and Oncology to join the Clinical Management team. You will help bring breakthrough science into medicines and diagnostics, while supporting growth and flexibility for the team.

This role involves leading site management and monitoring quality, sponsor communications, and audit readiness. Requires 2+ years as Clinical Lead in CRO, with Rare Diseases and Oncology experience, and strong financials knowledge.

Qualifications

• Bachelor's degree or international equivalent in clinical/biological/health-related field or equivalent work experience.
• 2+ years as Clinical Lead in CRO setting with onsite monitoring experience, RBM preferred.
• Experience in Rare Diseases and Oncology, ideally including CAR-T/Cell Gene Therapy and pediatric trials.
• Knowledge of clinical financials including budgets, pass-through, and resource management.

Responsibilities

• Serves as initial contact for site management and monitoring quality concerns, including initiation and oversight of sPIP.
• Plans, presents and participates in sponsor calls, providing status updates on clinical deliverables.
• Oversees quality of monitoring and site management deliverables via dashboards/reporting tools.
• Monitors clinical operations metrics, data entry timelines, actions, deviations, and backlog.
• Ensures audit readiness and supports sites in remediation of findings.
• Escalates performance concerns/quality events through established channels.

Skills

Clinical monitoring

Oncology experience

Rare diseases

Budget management

RBM awareness

Education

Bachelor's degree or international equivalent

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

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The minimum annualized starting base pay for this role is 251,000 PLN. The actual salary will be influenced based on a variety of factors such as qualifications, skills, competencies, and proficiency for the role.

We also offer comprehensive benefits packages, which may include health insurance, life insurance, retirement plan, paid time off, and an Employee Assistance Program.

Benefits:

• health insurance
• life insurance
• retirement plan
• paid time off
• Employee Assistance Program