Clinical Trial Management Associate

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.

Job Summary

The CTMA is a key member of Clinical Operations and will closely partner with the Associate Director, Clinical Program Management.

Job Responsibilities

• Accountable for study level tracking as assigned by the Clinical Project Manager; e.g. monitor visit tracking and sample tracking.
• Ensures patient enrollment activities are conducted in a timely manner.
• Provides study level information to enable accurate and efficient supply of clinical product to the sites.
• Acts as QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services.
• Accountable for ensuring that agendas for meetings are clear and distributed in advance; takes comprehensive and precise minutes for internal and external meetings.
• Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution remains on track.
• May participate in review of data listings and preparation of interim / final clinical study reports, including resolving data discrepancies.
• Provides regular study updates to the appropriate internal stakeholders.
• Maintains internal Clinical Operations databases and document repositories.
• Performs administrative duties in a timely manner as assigned.
• Assists with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations.
• Adheres to Clinical Operations processes and SOPs.

Qualifications

Technical Requirements and Skills :

Compensation :

Below is the pay range for this position that we reasonably expect to pay. Individual compensation is based on a number of factors including experience, education and skill set, and geographic location. This range is for the San Francisco Bay Area, California location and may be adjusted to the labor market in other geographic areas.

Pay range : $105,000 - $125,000 per annum.

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Salary : $105,000 - $125,000