Clinical Program Manager – Regional & Vendor Oversight

Planet Pharma; South San Francisco (CA); Sur place; USD 96 000 - 165 000; Plein temps

Résumé du poste

Planet Pharma is seeking a Global Clinical Project Manager to lead a Phase III program, coordinating across regions, CROs, vendors, and study sites to ensure consistent execution and high-quality results. The role emphasizes regulatory compliance, risk management, and cross-functional collaboration in a fast-paced environment.

The position focuses on start-up, enrollment, monitoring, site performance, and audit readiness, with regular updates to leadership and a need for travel domestically and

Qualifications

• At least 8+ years of relevant clinical research experience and a BS, BA, BN in a relevant scientific discipline.
• At least 8+ years of clinical research experience and an RN (2 or 3 year certificate)

Responsabilités

• 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.

Connaissances

Regional study oversight

CRO/vendor management

Operational risk management

Regulatory knowledge (FDA/EMA)

Cross-functional collaboration

Travel readiness

MS Office proficiency

Formation

BS/BA/BN in a relevant scientific discipline

RN (2-3 year certificate)

Outils

Microsoft Office

Description du poste

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.