Clinical Lead II — Rare Diseases & Oncology Trials

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 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.