Akero Therapeutics · 21 hours ago
Clinical Trial Management Associate (CTMA)
United States
Full-time
Remote
Entry Level
$81K/yr - $146K/yr
2+ years expAkero Therapeutics, a Novo Nordisk company, is focused on developing treatments for patients with serious metabolic diseases. The Clinical Trial Management Associate will support the Clinical Operations team by managing study tracking, ensuring timely patient enrollment, and maintaining trial master files, among other responsibilities.
BiotechnologyLife ScienceTherapeutics
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 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
Qualification
Required
At least 2+ years of relevant experience and a BS or BA in a relevant scientific discipline OR
At least 2+ 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
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)
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
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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