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Clinical Program Manager – Regional & Vendor Oversight

Planet Pharma Group · planet-pharma.com
South San FranciscoLead / ManagerContract
Apply on Planet Pharma Group’s site

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Clinical Program Manager – Global Study Lead
Planet Pharma Group · South San Francisco · found 5 d ago

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Subscribers got this job on 25 October 2026. New jobs reach them at 8 am and 6 pm, 5 days before they open here. Get the next one first

The job in short

Clinical program management, regional and vendor oversight.

GCPAuditClinical

Details

Found
5 d ago · posted 2026-10-23
Location as listed
South San Francisco, California
Role
Program / Project Manager
Source
The company’s own careers site

Full description

Global Clinical Project Manager – Phase III (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 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.

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