Clinical Operations Lead – Early Phase

Clinical Operations Lead – Early Phase Overview

• The Clinical Operations Lead – Early Phase oversees Phase 1 clinical development, ensuring operational excellence and compliance with regulatory standards.
• Lead strategic planning, initiation, and execution of clinical trials, including vendor selection, contracts, and proactive risk management.
• Collaborate globally across technical, project management, and regulatory teams to achieve organizational objectives.
• Provide input on training materials, clinical development plans, and regulatory documents to ensure timely delivery of quality trials.
• Drive site selection and subject recruitment programs to meet enrollment targets effectively.
• Champion efficient methods and processes to enhance reliability, efficiency, cost, and quality in clinical operations.
• Ensure trials are inspection-ready and comply with FDA/EMEA regulations, ICH guidelines, and GCP standards.
• Contribute to the development of clinical protocols, SOPs, and study reports supporting NDA submissions.

Clinical Operations Lead – Early Phase Key Responsibilities & Duties

• Develop and implement clinical operations strategies and methodologies for early-phase trials.
• Ensure clinical trials adhere to regulatory requirements and maintain inspection readiness.
• Oversee budgets, timelines, and program implementation in compliance with local and international guidelines.
• Provide operational input on training materials, standards, and clinical development plans.
• Collaborate with Clinical Trial Supply Unit for comparator sourcing strategies.
• Drive site selection and recruitment programs to achieve study enrollment goals.
• Lead global trials with a focus on reliability, efficiency, cost, and quality metrics.
• Develop clinical protocols, SOPs, and reports to support regulatory submissions.

Clinical Operations Lead – Early Phase Job Requirements

• Bachelor of Science (BS) in a relevant field; advanced degree preferred.
• 12+ years of clinical operations experience, preferably in biotechnology or pharmaceutical settings.
• Strong knowledge of FDA/EMEA regulations, ICH guidelines, and GCP standards.
• Proven experience in global trial management and patient recruitment strategies.
• Expertise in developing clinical protocols, SOPs, and regulatory documents.
• Demonstrated ability to lead business process transformations and deliver complex projects.
• Advanced skills in budget management, investigational product handling, and compliance monitoring.
• Strong leadership and collaboration skills across multidisciplinary teams.