Clinical Trial Lead

Overview

• Lead the operational strategy and execution of clinical trials, ensuring adherence to timelines, budgets, and quality standards.
• Collaborate with cross-functional teams to manage study feasibility, site selection, and regulatory compliance.
• Oversee vendor and Contract Research Organization (CRO) activities to ensure quality and efficiency.
• Contribute to clinical document development, including protocols, investigator brochures, and study reports.
• Act as the primary contact for site-related issues and procedural questions throughout the trial lifecycle.
• Support budget development and tracking, ensuring alignment with trial objectives and forecasts.
• Maintain the electronic Trial Master File (eTMF) and ensure compliance with regulatory standards.
• Provide mentorship to junior team members, fostering professional growth and operational excellence.

Key Responsibilities & Duties

• Develop and execute clinical trial operational strategies, ensuring alignment with organizational goals.
• Lead cross-functional Clinical Trial Teams (CTTs) and manage trial progress and issue resolution.
• Coordinate study start-up activities, including feasibility assessments and site regulatory preparations.
• Manage vendor contracts and oversee outsourced activities to ensure quality and compliance.
• Organize and chair trial sub-teams, ensuring effective collaboration and communication.
• Define and implement data review plans, ensuring scientific integrity and excellence.
• Support responses to quality assurance audits and regulatory inspections.
• Promote process improvements and knowledge sharing within the clinical operations department.

Job Requirements

• Bachelor of Science (BS) degree in a relevant scientific discipline is required.
• Minimum of 7 years of clinical research experience, with 10 years preferred.
• Strong oncology experience and understanding of biological principles in oncology.
• Proficiency in ICH/GCP guidelines and FDA regulatory standards.
• Ability to manage multiple clinical studies independently with minimal supervision.
• Experience in vendor management and clinical outsourcing specifications.
• Excellent communication skills and ability to collaborate across departments.
• Proven leadership and mentoring capabilities within clinical trial management teams.