Clinical Program Manager – Regional & Vendor Oversight

Akero Therapeutics

. Serve as the Global Study Lead for a large, global Phase 3 clinical study within a Phase 3 program .

Posted 10/27/2026full-timeRemote • United StatesSeniorLead💰 $152,700 - $267,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in leading global Phase 3 clinical studies, ensuring compliance with FDA/EMA regulations and ICH-GCP guidelines while effectively managing CROs and vendors. Exhibits strong operational oversight, risk management, and problem-solving skills to drive study performance and inspection readiness.

Highest-signal resume keywords

Global Phase 3 Clinical Study LeadershipCRO/Vendor ManagementRegulatory Compliance (FDA/EMA, ICH-GCP)Operational Performance MonitoringClinical Trial Inspection Readiness

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ExperienceStudy OversightRisk ManagementOperational Performance MonitoringDocumentation Remediation

Soft Skills

Problem-SolvingAttention to DetailCommunicationCollaboration

Certifications & Qualifications

BS, BA, BN in Relevant Scientific DisciplineRN (2 or 3 Year Certificate)

Industry Keywords

PharmaceuticalBiotechnologyHealthcareMASH (NASH)MASLDMetabolic Disease

About the role

Key responsibilities & impact

Serve as the Global Study Lead for a large, global Phase 3 clinical study within a Phase 3 program
Provide Clinical Operations oversight across assigned regions, CROs, and vendors
Ensure consistent execution against study plans, timelines, quality expectations, and regulatory requirements
Monitor study performance, identify operational risks and trends, and drive timely resolution of issues
Oversee 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
Drive timely mitigation, escalation, and corrective actions
Support inspection and audit readiness activities and remediation of documentation gaps
Ensure compliance with applicable regulations, ICH-GCP, SOPs, and study-specific plans
Partner with Clinical Research, Data Management, Biostatistics, Regulatory, and Quality stakeholders
Provide updates on regional and vendor performance, key risks, and inspection readiness to leadership and study teams
Contribute to key study documents and participate in CRO, vendor, and site oversight activities, including accompanied site visits
Manage or provide functional leadership to Clinical Operations personnel as required
Establish goals, measurements, interim reviews, and policy communication for reporting personnel

Requirements

What you’ll need

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)
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 travel up to 25%

Benefits

Comp & perks

Company bonus based on individual and company performance
Long-term incentive compensation
Medical, dental and vision coverage
Life insurance
Disability insurance
401(k) savings plan
Flexible spending accounts
Employee assistance program
Tuition reimbursement program
Group legal benefits
Critical illness insurance
Identity theft protection
Pet insurance
Auto/home insurance
Sick time policy
Flexible vacation policy
Parental leave policy