Akero Therapeutics · 2 hours ago
Clinical Trial Manager
United States
Full-time
Remote
Mid, Senior Level
$97K/yr - $179K/yr
4+ years expAkero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on developing treatments for serious metabolic diseases. The Clinical Trial Manager (CTM) will be a key member of Clinical Operations, assisting with the setup and management of clinical trials, ensuring study execution remains on track, and maintaining communication with stakeholders and CROs.
BiotechnologyLife ScienceTherapeutics
Responsibilities
Assist Clinical Program Manager with set-up of regional CRO and other vendors as required, including liaising with Global CRO to ensure site training and timely initiation
Day-to-day contact with counterpart at CRO and/or trial site; daily review and identification of potential issues or problems with the sites and communicates/escalates to Clinical Program Manager
Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution remains on track
Under supervision may serve as the key operational contact for Akero studies aiding in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs
Performs accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required
Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures under close supervision
Review of trip reports generated by CRO CRAs
Maintains study timelines
Coordinates 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
Qualification
Required
At least 4+ years of relevant experience and a BS or BA in a relevant scientific discipline OR
At least 4+ years of relevant experience and an RN (2- or 3-year certificate)
Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent
Experience as the regional lead for Europe, United States, and/or India
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
Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
High energy level, personal productivity, creativity and commitment
Team-player desiring 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)
Benefits
Medical, dental and vision coverage
Life insurance
Disability insurance
401(k) savings plan
Flexible spending accounts
Employee assistance program
Tuition reimbursement program
Voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance
Time off pursuant to its sick time policy
Flex-able vacation policy
Parental leave policy
Company
Akero Therapeutics
Akero Therapeutics is a biotechnology company focused on reversing the NASH epidemic by restoring the body’s metabolism to a balanced state.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$951.1MKey Investors
Pfizer Breakthrough Growth InitiativeHercules CapitalJanus Henderson Investors
2025-10-09Acquired
2024-03-05Post Ipo Equity· $366.9M
2023-05-15Post Ipo Equity· $124.2M
Leadership Team
Scott Gangloff
Chief Technology Officer
P
Patrick Lamy
Senior Vice President, Commercial Strategy
Recent News
2026-01-16
2026-01-16
2026-01-08
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