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Lead – Trial Master File

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Amylyx Pharmaceuticals

Amylyx Pharmaceuticals

201-500 employees

Develops treatments for neurodegenerative diseases


Senior, Expert

Cambridge, MA, USA

Healthcare Administration & Support
Nursing & Allied Health Professionals
Medical, Clinical & Veterinary
  • Bachelor's Degree with a minimum of 6 years of experience organizing and coordinating Trial Master Files for clinical trials
  • Experience leading projects and resources including employees, consultants and vendors
  • High level of competency with Veeva Vault eTMF and knowledge of the TMF Reference Model
  • Excellent organizational and problem-solving skills, able to work independently in a fast-paced environment
  • Efficient and effective time management skills with ability to successfully manage competing priorities
  • Strong attention to detail
  • Familiarity with US FDA, ICH/GCP, and European Regulatory Authority requirements as applicable to a study (or the countries where a study is conducted). GCP inspection experience preferred.
  • Provide leadership for all eTMF process
  • Establish, follow and oversee processes and procedures to support TMF set up, maintenance, and archiving for all Amylyx clinical studies
  • Oversee and facilitate the access management process
  • Serve as TMF Subject Matter Expert for the clinical study team
  • Manage TMF health and report on study-specific metrics
  • Work with internal and external TMF users to ensure resolution for quality issues
  • Develop and provide training on Veeva eTMF to internal and external TMF users
  • Participate in audits and inspection readiness activities
  • Identify areas for process improvements and work with stakeholders to implement solutions
  • Lead migrations of TMF content to Veeva Vault
  • Oversee Document Specialists and/or other clinical roles allocated to TMF activities
  • Ensure that study teams classify and index TMF content and metadata according to department standards, Good Documentation Practices, and Good Clinical Practice
Amylyx Pharmaceuticals

Amylyx Pharmaceuticals


Amylyx Pharmaceuticals specializes in developing treatments for neurodegenerative diseases, including their FDA-approved product, RELYVRIO™, which utilizes sodium phenylbutyrate and taurursodiol technologies for the treatment of ALS.

Company Stage


Total Funding



, Massachusetts



Growth & Insights

6 month growth


1 year growth


2 year growth