Clinical Program Manager – Global Study Lead

Clinical Project Manager – Global Study Lead (Contract)

Position Description:

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.