Lead – Trial Master File

THE OPPORTUNITY

The Lead, Trial Master File will be the Business Administrator for the Veeva Vault eTMF system and will provide leadership of Amylyx TMF strategy and process.  Reporting to the Global Head of Clinical Operations, this position will partner with internal and external study team members, IT and Quality Assurance to ensure efficient TMF processes are established and maintained.  May also provide oversight over Document Specialists or other team members dedicated to document processing.

THE RESPONSIBILITIES

• Provide leadership for all eTMF process, including but not limited to: procedural documents such as SOPs, Work Instructions or User Guides; TMF Management Plans and associated indexes; TMF migrations; Change Controls, Deviations and CAPAs.
• 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, by ensuring appropriate internal and external access, by monitoring user access and adding new team members or deactivating users no longer requiring access. 
• Serve as TMF Subject Matter Expert for the clinical study team and supporting cross-functional departments to ensure high quality documentation. Collaborate with cross functional study team to set up TMF structure.
• Manage TMF health and report on study-specific metrics according to TMF plan
• 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 to ensure.
• 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, if needed, working with the Clinical Leadership team to define resourcing and efforts required to complete TMF migrations
• 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.

REQUIRED QUALIFICATIONS

• 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.

WORK LOCATION AND CONDITIONS

• This is a remote friendly role, but you must reside and work within the United States, and in a state where Amylyx currently does business, to be considered. Any change in your remote location must be approved by Amylyx
• You will be required to follow Amylyx’s Remote Work Policy which includes:  
  • traveling to our corporate location in Cambridge, MA several times a year and attending other company-related events as necessary and requested, which may include travel by air, driving, or public transportation.
  • working in a setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote location
  • Information security protocols and steps to maintain confidentiality of Amylyx information, technology, and materials. ]