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.
Job Description
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
