Clinical Study Lead

Job Summary

A company is looking for a Clinical Study Lead to provide strategic and operational leadership for early-stage clinical trials in oncology.

Key Responsibilities

• Lead and coordinate all aspects of clinical trial execution for early-phase oncology studies, ensuring compliance with timelines, budgets, and quality standards
• Manage vendor selection processes and oversee CROs and clinical service providers, monitoring performance against KPIs
• Oversee study budgets, contracts, and essential trial documents, ensuring audit readiness and supporting study start-up activities

Required Qualifications

• Bachelor's degree in life sciences or related field required; advanced degree preferred
• 8-10 years of experience in clinical trial operations, including global and domestic trial management
• Strong working knowledge of FDA, ICH, and GCP regulations with experience in early-phase oncology trials
• Experience managing CROs, vendors, budgets, and contracts in a dynamic setting
• Demonstrated success in precision medicine or biomarker-driven clinical studies is highly desirable