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Manager, Trial Master File (Tmf) Operations

4-6 years
$122,000 – $133,000
10 May 5, 2025
Job Description
Job Type: Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.