Clinical Lead II - Dermatology

46 Premier Research Group SL; Spain; On-site; EUR 70,000 - 110,000; Full time

Job summary

Premier Research is seeking a Clinical Lead II - Dermatology to join our Clinical Management team in Spain. You will lead site management and monitoring activities, ensuring RBM and central monitoring excellence while driving study deliverables and audit readiness.

Ideal candidates hold a Life Sciences degree with 5+ years in clinical research, prior leadership in monitoring roles, and Dermatology experience in Phase II-III studies.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 5+ years of clinical research experience in CRO/sponsor/clinical operations.
• Previous Clinical Lead, Lead CRA, or CTM role experience.
• Experience managing monitoring activities and site performance.
• Strong RBM and centralized monitoring knowledge.
• Dermatology experience preferred, Phase II-III studies.
• Onsite monitoring experience preferred.
• Experience tracking enrolment, protocol deviations, SDV/SDR, and study metrics.
• Audit readiness and CAPA remediation experience.
• Budgeting, forecasting, and resource management knowledge.

Responsibilities

• Serves as initial point of contact for site management and monitoring quality concerns.
• Plans, presents, and participates in sponsor calls with status updates on clinical deliverables.
• Oversees the quality of clinical monitoring, central monitoring, and site management deliverables.
• Strong contributor to the central monitoring plan.
• Monitors clinical operations metrics, data entry timelines, and backlog.
• Ensures a state of audit readiness for both Premier and sites.
• Reviews audit findings and supports remediation/responses to site audit findings.
• Escalates through established channels for quality events and non-compliance.

Skills

Monitoring management

Site performance

Study deliverables

Leadership

Education

Bachelor's degree in Life Sciences or related field

Tools

RBM knowledge

Centralized monitoring

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 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.

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. 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.