Clinical Trial Management Associate (CTMA) at Akero Therapeutics

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Full Time

Start Date

Immediate

Expiry Date

01 May, 26

Salary

145820.0

Posted On

31 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trials, Attention To Detail, Verbal Communication, Written Communication, Interpersonal Skills, Presentation Skills, Medical Terminology, Word, PowerPoint, Excel, FDA Regulations, EMEA Regulations, ICH Guidelines, GCPs, Data Review, Problem Solving, Teamwork

Industry

Biotechnology Research

Description

COMPANY BACKGROUND Akero Therapeutics, a Novo Nordisk company, 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. The CTMA is a key member of Clinical Operations and will closely partner with the Senior Clinical Trial Manager. 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 Qualifications: 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 Experience & Skills 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). The base compensation range for this position is $81,010 to $145,820. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Akero Therapeutics, a Novo Nordisk company, offers long-term incentive compensation depending on the position's level or other company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy. The job posting is anticipated to close on Feb 9, 2026. The Company may however extend this time-period, in which case the posting will remain available on our careers website at https://akerotx.com/job-opportunities. EEO Statement: Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

Responsibilities

The Clinical Trial Management Associate (CTMA) is responsible for study level tracking, ensuring timely patient enrollment activities, and maintaining Trial Master Files. They will also provide regular study updates and assist with administrative duties related to clinical trial operations.