Clinical Operations Lead - Early Phase

Job DetailExperience Level DirectorDegree Type Bachelor of Science (BS)Employment Full TimeWorking Type HybridJob Reference 0000020759Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful clinical operations initiatives in early-phase trials. Collaborate globally to ensure compliance and operational excellence. Drive innovation in trial management and regulatory submissions.Job DescriptionClinical Operations Lead – Early Phase OverviewThe 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 & DutiesDevelop 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 RequirementsBachelor 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.