Manager, Trial Master File (TMF) Operations
Eikon TherapeuticsCalifornia, United States • Jersey City, New Jersey, United States
Posted October 6, 2025
122000 - 133000 USD year
Full Time
About the Company
Eikon Therapeutics is a biopharmaceutical company leveraging revolutionary technology to discover novel treatments for life-threatening diseases. Utilizing microscopes that enable real-time molecular-resolution measurements of protein movement in living cells, Eikon's platform identifies compound-protein interactions and explores novel biology with high-content data sets, facilitating drug discovery and the creation of life-saving therapies. The company seeks passionate interdisciplinary scientists to drive scientific exploration and innovation.
Job Description
Eikon Therapeutics is seeking a Manager, TMF Operations to ensure accurate and high-quality Trial Master File (TMF) documentation. This role involves collaboration with clinical study teams, compliance review, and TMF set-up and quality assurance to support regulatory inspection readiness for clinical trials. The position requires 3+ days a week onsite presence in NJ or CA.
Requirements
- 6+ years of experience with a Bachelor's degree or 4+ years with a post-graduate degree
- Experience in pharmaceutical/biotechnology/CRO organization’s TMF/records management function (preferred)
- Experience with eTMF or Veeva eTMF preferred
- Basic understanding of ICH-GCP guidelines and FDA/EMA/PMDA regulations
- General knowledge of clinical trials and trial planning
Benefits
- 401k plan with company matching
- Medical (premiums covered by Eikon at 95%)
- Dental and vision insurance (premiums covered by Eikon at 100%)
- Mental health and wellness benefits
- Life/AD&D Insurance (premiums covered by Eikon at 100%)
- Enhanced parental leave benefit
- Daily subsidized lunch program
- Bonus and equity compensation
