Clinical Lead II – Rare Diseases / Oncology

Overview

In this Clinical Lead II role, you will be the primary point of contact for site management and monitoring quality, driving performance improvements and ensuring audit readiness. You will represent Clinical and SSU in sponsor calls and oversee monitoring deliverables through dashboards and central monitoring plans. The position focuses on Rare Diseases and Oncology, with potential exposure to CAR-T/Cell Gene Therapy and pediatric trials, contributing to high-quality, patient-focused clinical programs. You’ll work closely with cross-functional teams to manage timelines, risk, and data integrity, shaping delivery for sponsors and sites.

Responsibilities

• Serve as first contact for site management and monitoring quality concerns and initiate site performance improvement plans
• Plan, present, and participate in sponsor calls, delivering status on clinical deliverables
• Oversee quality of monitoring, central monitoring, and site management via dashboards and reporting tools
• Monitor operations metrics, timelines, data entry, deviations, queries aging, SDR/SDV backlog, and monitoring visit turnaround
• Maintain audit readiness for Premier and sites; respond to audit findings and support remediation
• Escalate quality events and performance concerns through established channels (CRA/CM/SSU)

Key requirements

• Bachelor’s degree in a clinical, biological, scientific, or health-related field or equivalent work experience
• At least 2 years as a Clinical Lead (global) in a CRO with onsite monitoring experience
• Experience in Rare Diseases and Oncology; ideally managing trials (not solely CRA)
• Experience with Risk-Based Monitoring and pediatric trials; experience in CAR-T/Cell Gene Therapy preferred
• Knowledge of clinical financials including budgets, pass-through, and resource management

• Strong communication and presentation skills
• Quality-focused and proactive problem solving
• Cross-functional collaboration
• Dashboarding and reporting tools
• Central monitoring processes
• Risk-based monitoring concepts

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