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 environmentPrior experience as a Clinical Lead, Lead CRA, Senior CRA, CTM, or equivalent study oversight roleDemonstrated experience managing monitoring activities, site performance, and study deliverablesStrong understanding of Risk-Based Monitoring (RBM), centralized monitoring, visit oversight, and issue escalation processesDermatology experience strongly preferred, ideally supporting Phase II-III dermatology studiesPrevious onsite monitoring experience preferredOversight of CRA performance, monitoring quality, and site management activitiesExperience tracking key clinical metrics, including enrolment, protocol deviations, queries, SDV/SDR completion, monitoring report timeliness, and site action plansAudit and inspection readiness experience, including CAPA management and remediation supportExperience managing study risks, escalations, quality events, and compliance issuesWorking knowledge of study budgets, forecasting, and resource managementSummaryLocation: United Kingdom; Spain; Czech Republic; PolandType: Full time
Clinical Lead II - Dermatology employer: Premier Research
At Premier Research, we pride ourselves on being an exceptional employer that values the contributions of our team members in the vital field of clinical research. Our supportive work culture fosters professional growth and offers flexible working arrangements, ensuring a healthy work-life balance while you play a crucial role in delivering innovative medical solutions. With opportunities for continuous development and collaboration within a global team, you'll find meaningful and rewarding employment that truly makes a difference in patients' lives.
