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← Oruka Therapeutics

Trial Master File (TMF) Associate

Oruka Therapeutics
Location
Menlo Park, California, United States; Remote; Waltham, Massachusetts, United States
Posted
9 days ago
Department
Clinical Operations
Salary
$104,000 - $125,000
What they actually want (must-haves)
  • Bachelor's degree in Life Sciences, Health Sciences, or related fields or equivalent
  • 2-4+ years of experience in TMF management, clinical document management, clinical operations, or clinical research within biotechnology, pharmaceutical, or CRO environments
  • Working knowledge of the CDISC TMF Standard Model, ICH-GCP R(3) guidelines, 21 CFR Part 11, and applicable FDA and global regulatory requirements
  • Experience maintaining electronic Trial Master Files (eTMF) in regulated clinical trial environments
  • Hands-on experience with Veeva Vault eTMF and/or Trial Interactive platforms
  • Experience with TMF quality control, completeness reviews, reconciliation activities, and inspection readiness support
Nice to have
  • Experience supporting FDA BIMO regulatory inspections
  • Experience supporting global clinical studies across multiple phases and working directly with CROs and external vendors
  • Familiarity with CTMS platforms and TMF-related inspection preparation activities
  • Experience supporting SOP development, TMF training, or process improvement initiatives
What the job really is

The Trial Master File (TMF) Associate will manage and ensure the quality of clinical trial documentation throughout the study lifecycle. This role involves maintaining TMF records, performing quality control reviews, monitoring TMF health metrics, and supporting audit preparations. The TMF Associate will collaborate with Clinical Operations, CROs, and vendors to ensure compliance with regulatory requirements and company procedures.

Benefits
  • A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients
  • Competitive salary and benefits package
  • A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work
  • Opportunities for professional growth and development
Things to weigh
  • Remote or hybrid work options available, but in-office presence may be required for those near Waltham, MA or Menlo Park, CA
  • Salary range provided is specific to the Associate level and may vary based on experience and location
  • No specific details on the benefits package beyond competitive salary and opportunities for growth
Job score4/5
Benefits2/5
Freshness5/5
Career value4/5
Role clarity4/5
Pay transparency5/5

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