Job Title: Manager, Trial Master File (TMF) Operations
Company: Eikon Therapeutics
Location: Millbrae, CA / Jersey City, NJ / New York, NY (Hybrid – minimum 3 days onsite/week)
Job Type: Full-time
Salary Range: $122,000 – $133,000 (plus bonus & equity)
About the Company
Eikon Therapeutics is a biotech company leveraging Nobel Prize-winning innovations in live-cell imaging and molecular biology to discover breakthrough treatments for life-threatening diseases.
Role Summary
As a Manager, TMF Operations, you will serve as the subject matter expert for Trial Master File processes, ensuring timely, accurate, and compliant TMF documentation. You’ll work closely with cross-functional teams to support inspection readiness, documentation quality, and continuous process improvement in clinical operations.
Key Responsibilities
Ensure TMF-related activities comply with SOPs, GCP, ICH, and study-specific processes
Set up TMFs and Expected Document Lists (EDLs) with study teams
Lead creation and approval of TMF plans and filing structures
Conduct periodic TMF reviews for quality, completeness, and timeliness
Track TMF quality trends and escalate issues proactively
Perform technical QC of documents, manage scanning, indexing, and issue workflows
Support audit/inspection preparation and archival of TMFs
Train internal teams and provide TMF process guidance
Contribute to process improvements, SOPs, and job aids related to TMF activities
Collaborate with vendors and internal departments to ensure TMF compliance
Qualifications
Bachelor's degree with 6+ years OR postgraduate degree with 4+ years in clinical document/TMF management
Experience in pharma, biotech, or CRO TMF operations strongly preferred
Familiarity with eTMF systems (Veeva preferred), ALCOA+, GCP, and FDA/EMA/PMDA regulations
Understanding of TMF Reference Model and good documentation practices
Proficient with MS Office, Adobe Acrobat, and SharePoint
Experience in audit/inspection support is a plus
Excellent time management and communication skills
Willingness to travel as needed
Compensation & Benefits
Competitive salary with bonus and equity options
401(k) plan with company match
Medical (95%), dental and vision (100%) premiums covered
Mental health and wellness programs
Paid time off, holidays, and summer/winter company shutdowns
Fully covered life/AD&D insurance plus optional extras
Enhanced parental leave
Subsidized daily lunch for onsite employees
Diversity & Inclusion
Eikon Therapeutics is an equal opportunity employer committed to a diverse and inclusive workplace.
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