Clinical Lead II - Dermatology

61 Premier Research Poland Sp. z.o.o; 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 Poland Sp. z o.o. is seeking a Clinical Lead II - Dermatology to join our Clinical Management team. You will oversee site performance, risk-based monitoring, and QA readiness while collaborating with sponsors to deliver dermatology studies.

Ideal candidates have 5+ years in clinical research, prior on-site monitoring, and strong leadership in CRA-like roles. Dermatology experience and RBM knowledge are preferred; you will help drive high-quality results for Phase II-III trials.

Qualifications

• Bachelor's degree in Life Sciences or related field with 5+ years clinical research experience.
• Previous on-site monitoring experience and roles like Clinical Lead or Lead CRA.
• Experience with RBM, centralized monitoring, and issue escalation.

Responsibilities

• Serve as initial point of contact for site management and monitoring quality concerns.
• Plan, present, and participate in sponsor calls with status updates on deliverables.
• Oversee the quality of monitoring, central monitoring, and site deliverables.
• Monitor clinical operations metrics, timelines, and data-entry progress.
• Ensure audit readiness and respond to audit findings; support remediation.
• Escalate quality events, data breaches, or other issues per process.

Skills

Clinical monitoring

RBM

Site management

Audit readiness

Monitoring metrics

Education

Bachelor's degree in Life Sciences

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.

Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems.

Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies.

As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning. Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests.

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose.

Premier is a place where you can change lives, and feel rewarded and celebrated.

We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.