Clinical Lead II - Rare Diseases / Oncology

11 Premier Research International LLC; Vancouver; On-site; CAD 110,000 - 145,000; Full time

Job summary

Premier Research is seeking a Clinical Lead II specializing in Rare Diseases and Oncology to guide site management and monitoring quality across trials. You will oversee monitoring quality, central monitoring, and performance dashboards, ensuring audit readiness and timely remediation.

You bring at least 2 years as a Clinical Lead in a CRO, with onsite monitoring and experience in Rare Diseases and Oncology, including CAR-T or Cell Gene Therapy.

Qualifications

• Bachelor’s degree or international equivalent in a clinical, biological, scientific, or health-related field or equivalent work experience.
• At least 2 years of experience as a Clinical Lead in a CRO, onsite monitoring with Risk-Based Monitoring.
• Experience in both Rare Diseases and Oncology is required.
• Experience as Clinical Lead managing trials (not only CRA) is preferred.
• Experience in biliary liver disease, Oncology with CAR-T or Cell Gene Therapy; pediatric trials is a plus.
• Knowledge of clinical financials: budgets, pass-through, and resource management.

Responsibilities

• Serve as initial point of contact for site management and monitoring quality concerns, initiating and overseeing sPIPs.
• Plan, present, and participate in sponsor calls, providing status updates on clinical deliverables.
• Oversee quality of monitoring, central monitoring, and site management deliverables using dashboards and reports.
• Contribute to the central monitoring plan as a key team member.
• Monitor clinical operations metrics, timelines, data entry, actions, deviations, queries, and SDR/SDV backlog.
• Ensure audit readiness for Premier and sites; respond to audit findings and support remediation.
• Escalate quality events to CRA/CM/SSU per established channels.

Skills

Clinical Lead CRO experience onsite

Rare Diseases experience

Oncology experience

CAR-T / Cell Gene Therapy

Clinical financials knowledge

Education

Bachelor’s degree or international equivalent in clinical/biological/health field

Job description

Premier Research is looking for a Clinical Lead II - Rare Diseases / Oncology 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, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience
• At least 2 years of experience as a Clinical Lead (ideally global) gained in a CRO setting and must have prior onsite monitoring experience, ideally to include Risk-Based Monitoring.
• Must have prior experience in both Rare Diseases and Oncology.
• This will ideally have been gained as a Clinical Lead managing trials vs solely in a CRA capacity.
• Biliary liver disease therapeutic experience, Oncology experience in CAR-T and / or Cell Gene Therapy in addition to experience working on pediatric trials will be the optimum.
• Working knowledge of clinical financials including understanding of budgets, pass- through 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. Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests. 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. Premier is a place where you can change lives, and feel rewarded and celebrated. 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.