Clinical Program Manager

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 provide regional and vendor oversight across a global Phase 3 program, helping drive consistent study execution, operational quality, and inspection readiness across regions, CROs, vendors, and study sites.

• Job Responsibilities Provide Clinical Operations oversight across assigned regions, CROs, and vendors within a large, global Phase 3 program, ensuring consistent execution against study plans, timelines, quality expectations, and regulatory requirements.

• Partner closely with Global Study Leads, regional teams, CROs, and vendors to monitor study performance, identify operational risks and trends, and drive timely resolution of issues.

• Provide oversight of regional study execution, including site start-up, enrollment, monitoring, site performance, and ongoing study conduct.

• Monitor CRO and vendor performance, study metrics, and operational trends; identify risks and gaps and drive timely mitigation, escalation, and corrective actions

• Analyze study metrics and operational trends across regions and vendors to identify areas requiring additional oversight, escalation, or mitigation.

• Support inspection and audit readiness activities, including assessment of study documentation, identification and remediation of gaps, and coordination of readiness activities with internal teams, CROs, vendors, and study sites.

• Ensure study activities and documentation comply with applicable regulations, ICH-GCP, SOPs, and study-specific plans.

• Partner with cross-functional stakeholders, including Clinical Research, Data Management, Biostatistics, Regulatory, and Quality, to support successful program execution.

• Provide regular updates on regional and vendor performance, key risks, and inspection readiness to Clinical Operations leadership and study teams.

• Contribute to key study documents and participate in CRO, vendor, and site oversight activities, including accompanied site visits, as appropriate.

• As required, manage or provide functional leadership to Clinical Operations personnel supporting the program.

• 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 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 with regional study oversight, CRO/vendor management, and operational performance.

• Experience supporting clinical trial inspection and audit readiness, including identification and remediation of operational or documentation gaps.

• Strong operational, problem-solving, and risk management skills with exceptional attention to detail.

• Strong knowledge of FDA/EMA regulations, ICH guidelines, and GCP requirements.

• Excellent communication and collaboration skills with the ability to work effectively across global, cross-functional teams.

• 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.