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Full-Time

Lead – Trial Master File

Confirmed live in the last 24 hours

Amylyx Pharmaceuticals

Amylyx Pharmaceuticals

201-500 employees

Develops treatments for neurodegenerative diseases

Biotechnology

Senior, Expert

Cambridge, MA, USA

Category
Healthcare Administration & Support
Nursing & Allied Health Professionals
Medical, Clinical & Veterinary
Requirements
  • 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.
Responsibilities
  • 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

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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

IPO

Total Funding

$548.9M

Headquarters

, Massachusetts

Founded

2013

Growth & Insights
Headcount

6 month growth

0%

1 year growth

17%

2 year growth

70%