Trial Master File (TMF) Associate
Oruka Therapeutics · Menlo Park, California, United States; Remote; Waltham, Massachusetts, United States
Posted 5 days ago · $104,000 - $125,000
or apply directly on Oruka Therapeutics's site. We never take the application ourselves.
Is this posting real?
- This role has been open
- 5 days Oruka Therapeutics's roles stay open a median of 45 days
- Reposted
- No
- Salary listed
- Yes 83% of Oruka Therapeutics's roles list one
- Ghost-job risk at Oruka Therapeutics
- high 9 stale, 0 reposted of 12 open
- Hiring momentum
- 22 roles opened in the last 90 days ↑ up vs. the prior 90 days
- Last confirmed on the employer's board
- 2026-09-17
Measured from postings appearing on and disappearing from Oruka Therapeutics's own greenhouse board since 2026-08-03. Full hiring picture for Oruka Therapeutics.
About this role
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
- 2/5
- freshness
- 5/5
- career value
- 4/5
- role clarity
- 4/5
- pay transparency
- 5/5
Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Oruka Therapeutics as an employer.
What you need
- 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 you get
- 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
Worth weighing
- 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
Summarised from Oruka Therapeutics's posting. Read the full original.
Listed by Oruka Therapeutics on their greenhouse job board, last confirmed open on 2026-09-17. PitchMeAI is not the employer.
More roles at Oruka Therapeutics
- Sr. Associate/Manager Project Management & OperationsWaltham, Massachusetts, United States
- Biosample Operations AssociateMenlo Park, California, United States; Remote; Waltham, Massachusetts, United States