Clinical Project Manager – Global Study Lead (Contract) Position Description: Job Summary The Clinical Program Manager (CPM) is a key member of Clinical Operations and will closely partner with the Senior Director of Clinical Program Management. The CPM will serve as the Global Study Lead for a large, global Phase 3 clinical study within a Phase 3 program, with accountability for the operational planning, execution, oversight, and delivery of the study. Job Responsibilities • Serve as the Global Study Lead and primary Clinical Operations point of contact for a large, global Phase 3 study, providing end-to-end operational leadership from start-up through closeout. • Serve as the Global Study Lead and primary Clinical Operations point of contact for a large, global Phase 3 study, providing end-to-end operational leadership from start-up through closeout. • Lead global study planning and execution, including start-up, enrollment, site management, and ongoing study conduct through CRO partners. • Provide oversight of CROs and external vendors, ensuring alignment on priorities, timelines, deliverables, quality, risks, and study performance. • Partner with cross-functional stakeholders to drive successful study execution and lead the identification, mitigation, escalation, and resolution of operational risks and issues. • Develop and manage study timelines, enrollment projections, operational plans, budgets, and key study metrics. • Provide regular updates to internal stakeholders and senior leadership on study progress, key risks, mitigation plans, and decisions. • Review key study documents and oversee monitoring activities, study quality, and maintenance of study documentation and systems. • Support inspection and audit readiness and ensure compliance with applicable regulations, ICH-GCP, SOPs, and study-specific plans. • As required, manage or provide functional leadership to Clinical Operations personnel supporting the study. Qualifications • At least 8+ years of relevant clinical research experience and a BS, BA, BN in a relevant scientific discipline or • At least 8+ years of clinical research experience and an RN (2 or 3 year certificate) Technical Requirements and Skills: • Relevant clinical trial experience supporting or leading a large, Global Phase 3 program in the pharmaceutical, biotechnology, or health care industry or equivalent. • Relevant clinical trial experience leading large, global Phase 3 studies or programs within the pharmaceutical, biotechnology, or healthcare industry. • MASH (formerly NASH), MASLD, and/or metabolic disease experience preferred. • Demonstrated experience leading global study execution and CRO/vendor oversight, including management of timelines, risks, and operational performance. • Strong operational leadership, problem-solving, and risk management skills with exceptional attention to detail. • Experience with clinical trial inspection and audit readiness preferred. • Strong knowledge of FDA/EMA regulations, ICH guidelines, and GCP requirements. • Excellent communication and collaboration skills with the ability to lead effectively across global, cross-functional teams and senior stakeholders. • Ability to work independently, manage multiple priorities in a fast-paced environment, and travel domestically and internationally as required. • Proficiency with Microsoft Office applications, including Word, PowerPoint, and Excel.