Clinical Program Manager – Regional & Vendor Oversight

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $152.7k - $267.3k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🏥 Clinical Operations

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Akero Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2017

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Akero Therapeutics is a company pioneering novel therapies to transform the lives of people living with serious metabolic diseases. Their flagship program, Efruxifermin (EFX), is aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) and is currently undergoing multiple clinical trials. Akero is committed to advancing medicine in the field of metabolic diseases and has a strong focus on research, development, and clinical studies.

📋 Description

• 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

• 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

• 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