CLINICAL PROGRAM MANAGER – REGIONAL & VENDOR OVERSIGHT

Clinical Program Manager – Regional & Vendor Oversight

Location: South San Francisco, California

Category: Clinical Development and Operations

Salary: Apply for details

Country: United States

Employment: Contract

Worksite: On-Site

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Job 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.
  
  

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.

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The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.