Senior Clinical Trial Manager - Remote

Overview

Akero Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with MASH(metabolic dysfunction-associated steatohepatitis).

We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others.

In Short

• Key member of Clinical Operations overseeing EMEA region.
• Assists with set-up of regional CRO and vendor management.
• Leads regulatory submission strategies and package reviews.
• Identifies operational challenges and provides solutions.
• Coordinates study site selection and implementation.
• Ensures compliance with study procedures and regulatory requirements.
• Mentors junior team members.
• Maintains study timelines and data integrity.
• Provides regular updates to stakeholders.
• Performs administrative duties as needed.

Requirements

• 6+ years of relevant experience with a BS/BA or RN.
• Clinical trial experience in the pharmaceutical or healthcare industry.
• Experience as a regional lead for EMEA required.
• Excellent attention to detail and communication skills.
• Familiarity with medical/scientific terminology.
• Knowledge of FDA/EMEA regulations and GCPs.
• Strong knowledge of Excel preferred.
• Ability to participate in strategic initiatives.
• High energy level and team-player mentality.
• Prior experience in a biotech environment preferred.

Benefits

• Competitive salary range based on experience and location.
• Opportunity to work remotely.
• Involvement in groundbreaking clinical research.
• Collaborative and innovative work environment.
• Potential for travel as required.