Senior Clinical Lead, Dermatology - RBM & Site Oversight

Premier Research Group

Polska

On-site

PLN 226,000 - 276,000

Full time

3 days ago
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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 our Clinical Management team. This role focuses on monitoring quality, RBM, and study deliverables across dermatology trials, with oversight of site management and central monitoring.

You will coordinate sponsor calls, present status updates, and ensure audit readiness. A strong background in dermatology studies and site oversight is essential for success at Premier Research.

Qualifications

  • 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.
  • Experience as Clinical Lead, Lead CRA, Senior CRA, CTM, or equivalent study oversight role.
  • Experience managing monitoring activities, site performance, and study deliverables.
  • Strong understanding of RBM, centralized monitoring, visit oversight, and issue escalation processes.
  • Dermatology experience preferred, ideally Phase II-III dermatology studies.
  • Previous onsite monitoring experience preferred.
  • Oversight of CRA performance, monitoring quality, and site management activities.
  • Experience tracking enrolment, protocol deviations, queries, SDV/SDR, monitoring 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.

Responsibilities

  • Serves as initial point of contact for site management and monitoring quality concerns, including sPIP initiation and oversight.
  • Plans, presents, and participates in sponsor calls, providing status updates on clinical deliverables.
  • Oversees the quality of monitoring, central monitoring, and site management deliverables with dashboards/reporting tools.
  • Monitors clinical operations metrics, data entry timelines, SDR/SDV backlog, and visit report turnaround timelines.
  • Ensures audit readiness for Premier and sites; responds to audit findings and supports remediation.
  • Escalates quality concerns and events through established channels.

Skills

Clinical research
RBM
On-site monitoring
Monitoring metrics
Audit readiness

Education

Bachelor's degree in Life Sciences or related

Job description

Premier Research is seeking a Clinical Lead II - Dermatology to join our Clinical Management team. This role focuses on monitoring quality, RBM, and study deliverables across dermatology trials, with oversight of site management and central monitoring.

You will coordinate sponsor calls, present status updates, and ensure audit readiness. A strong background in dermatology studies and site oversight is essential for success at Premier Research.

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