Clinical Program Manager - Global Study Lead

Reference: 631953Posted: 2026-10-23Location: South San Francisco, CaliforniaCompany: Planet Pharma GroupContact: ApplicationsEmail: View email address on click.appcast.io 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 ResponsibilitiesServe 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.QualificationsAt least 8+ years of relevant clinical research experience and a BS, BA, BN in a relevant scientific discipline orAt 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.