Clinical Lead II - Dermatology

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

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Employee Assistance Program

Job summary

Premier Research is seeking a Clinical Lead II - Dermatology to join the Clinical Management team in Poland. The role focuses on leading site management, monitoring quality, and sponsor communications while ensuring RBM and centralized monitoring excellence.

The position requires 5+ years in clinical research, dermatology study experience preferred, and strong audit readiness. Competitive compensation with extensive benefits is offered.

Qualifications

• Minimum 5+ years of clinical research experience within CRO, sponsor, or clinical operations environment.
• Experience as Clinical Lead, Lead CRA, Senior CRA, CTM, or similar study oversight role.

Responsibilities

• Serves as initial point of contact for site management and monitoring quality concerns, including initiation and oversight of sPIP.
• Plans, presents, and participates in sponsor calls,代表ing Clinical and SSU functions with status updates on clinical deliverables.
• Oversees the quality of clinical monitoring, central monitoring, and site management deliverables through dashboards/reporting tools; contributes to central monitoring plan.
• Monitors clinical operations metrics, timelines, data entry timelines, protocol deviations, queries aging reports, SDR/SDV backlog and monitoring visit report turnaround timelines.
• Ensures audit readiness for Premier and sites; reviews audit findings and supports remediation/responses.
• Escalates performance concerns, quality events, data breaches, and other events via established channels.

Skills

Clinical research experience

Site management

RBM knowledge

Audit readiness

Onsite monitoring

Budget forecasting

Education

Bachelor's degree in Life Sciences, Health Sciences, Nursing, or related field

Tools

Reporting tools

Job description

Premier Research is looking for a Clinical Lead II - Dermatology 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 in Life Sciences, Health Sciences, Nursing, or related field (or equivalent clinical research experience)
• 5+ years of clinical research experience within a CRO, sponsor, or clinical operations environment
• Prior experience as a Clinical Lead, Lead CRA, Senior CRA, CTM, or equivalent study oversight role
• Demonstrated experience managing monitoring activities, site performance, and study deliverables
• Strong understanding of Risk-Based Monitoring (RBM), centralized monitoring, visit oversight, and issue escalation processes
• Dermatology experience strongly preferred , ideally supporting Phase II-III dermatology studies
• Previous onsite monitoring experience preferred
• Oversight of CRA performance, monitoring quality, and site management activities
• Experience tracking key clinical metrics, including enrolment, protocol deviations, queries, SDV/SDR completion, monitoring report timeliness, and site action plans
• Audit and inspection readiness experience, including CAPA management and remediation support
• Experience managing study risks, escalations, quality events, and compliance issues
• Working knowledge of study budgets, forecasting, 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.