Clinical Lead II - Dermatology

premierresearch; Espagne; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Premier Research in Spain is seeking a Clinical Lead II - Dermatology to join our Clinical Management team. You will drive site management and monitoring quality across dermatology trials, coordinating with sponsors and SSU to deliver on study deliverables.

The role requires 5+ years in clinical research, experience as a lead role, strong RBM knowledge, and proven ability to escalate and resolve quality issues. Dermatology expertise and onsite monitoring are highly valued.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 5+ years of clinical research experience in CRO/sponsor/operations.
• Experience as Clinical Lead or equivalent study oversight role.
• Experience managing monitoring activities and site performance.
• Strong RBM and centralized monitoring knowledge.
• Dermatology experience preferred, Phase II–III.
• Onsite monitoring experience preferred.
• Audits readiness and CAPA remediation experience.
• Experience overseeing CRA performance and site management.
• Budgeting, forecasting, and resource management knowledge.

Responsabilités

• Serves as initial contact for site management and monitoring quality concerns, incl. initiation of site performance improvement plans (sPIP).
• Plans, presents, and participates in sponsor calls, representing Clinical and SSU by providing status updates on clinical deliverables.
• Oversees the quality of clinical monitoring, central monitoring, and site management deliverables through dashboards/reporting tools.
• Monitors clinical operations metrics and timelines; tracks SDR/SDV backlog and monitoring report turnaround.
• Ensures audit readiness and addresses audit findings with sites for remediation.
• Escalates quality events and compliance issues through established channels.

Connaissances

Clinical research

RBM

Site management

Monitoring oversight

Audit readiness

CAPA management

Budget forecasting

Regulatory compliance

Dermatology experience

Formation

Bachelor's degree in Life Sciences or related field

Description du poste

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