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Clinical TMF Operations Administrator at Akero Therapeutics - ApplyBlast

Clinical TMF Operations Administrator

Akero Therapeutics

3 months ago

Onsite

Full Time

Senior

0 applicants

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About this role

The Clinical TMF Operations Administrator leads Trial Master File activities for Phase 3 clinical development, ensuring compliance with regulatory standards and industry best practices. This role oversees document management processes, manages quality workflows, and provides subject matter expertise for audits and inspections. The position requires significant experience collaborating with cross-functional teams, CROs, and regulatory authorities to support scientific presentations and regulatory submissions.

Responsibilities

Lead TMF activities across trial phases ensuring consistent communication with teams
Oversee implementation and maintenance of processes for cataloging and storing TMF records
Manage eTMF health by overseeing Quality Issue workflows and ensuring timely remediation
Provide subject matter expertise for audits and inspections including preparation and support
Contribute to TMF strategy and continuous improvement initiatives including SOP development

Skills

Qualifications

Bachelor's degree in a related discipline4+ years of work experience in clinical research2-3+ years in eTMF document managementExperience with DIA (CDISC) TMF Reference ModelKnowledge of ICH Guidelines

About Akero Therapeutics

akerotx.com

Headquarters

South San Francisco, California, United States

Company Size

11-50 employees

Founded

2017

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Akero Therapeutics is a clinical-stage biopharmaceutical company focused on developing transformational therapies for metabolic dysfunction‑associated steatohepatitis (MASH) and related metabolic diseases. Their lead investigational candidate, efruxifermin (EFX), is an engineered FGF21‑based therapy designed to improve metabolic health and reduce liver disease in people with MASH. Akero advances programs through clinical development with the goal of addressing underlying metabolic drivers of liver disease and improving long‑term patient outcomes.