COMPANY BACKGROUND

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 Senior Clinical Trial Manager in central laboratory and third-party laboratory oversight. While a strong understanding of basic clinical operations is expected, the primary emphasis of this position will be on laboratory-related activities.

TECHNICAL REQUIREMENTS AND SKILLS

• Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent
• Prior experience working with central laboratories or other third-party laboratories in clinical trials is highly preferred
• Excellent attention to detail, verbal, written, interpersonal and presentation skills are required
• Must be familiar with routine medical/scientific terminology
• Must be familiar with Word, PowerPoint, and Excel
• Must have working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
• Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
• High energy level, personal productivity, creativity and commitment.
• Team-player with desire to work in a fast-moving, dynamic start-up environment.
• This position is for remote work but may require domestic or international travel as required (valid travel documents must be obtainable).

QUALIFICATIONS

• At least 2+ years of relevant experience and a BS or BA in a relevant scientific discipline OR
• At least 2+ years of experience and an RN (2 or 3 year certificate)

• Laboratory Vendor Oversight:
• Assist the Clinical Trial Manager in the day-to-day management and oversight of the central laboratory vendor and third-party laboratory vendors (tracking deliverables, communication, and issue resolution).
• Track and monitor central laboratory performance metrics, including sample receipt, processing, analysis, shipment, and data delivery timelines.
• Support the review of laboratory manuals and study plans.
• Assist in the coordination of sample management activities between clinical sites, the central laboratory, and other relevant parties.
• Help manage and track laboratory kits and supplies.
• Support the resolution of laboratory-related issues and discrepancies, escalating to the Clinical Trial Manager as needed.
• Assist in the review of laboratory-related payments and invoices.
• Maintain and organize central laboratory-related documentation in the Trial Master File (TMF).
• Support audit and inspection readiness activities related to the central laboratory.
• Basic Clinical Operations Support:
• 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 and is comfortable communicating with site personnel.
• 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.
• Assist with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations.
• Adheres to Clinical Operations processes and SOPs