Associate, TMF Documentation

Axsome Therapeutics(1 month ago)

HybridFull TimeJunior$94,840 - $124,706 (estimated)Clinical Operations

About this role

The Associate, TMF Documentation is an early-career clinical operations role responsible for supporting the quality and compliance of Trial Master Files to ensure they remain inspection-ready. The position is based at Axsome’s New York City headquarters with an on-site requirement of at least three days per week. The role partners with study teams and cross-functional stakeholders to support the clinical document lifecycle and maintain adherence to regulatory standards.

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Required Skills

TMF Management
Document Indexing
Document Review
Tracker Maintenance
Inspection Readiness
Audit Support
Regulatory Knowledge
SOPs
ICH/GCP
Team Collaboration

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About Axsome Therapeutics

axsome.com

Axsome Therapeutics is a biopharmaceutical company focused on developing novel therapies for central nervous system (CNS) conditions that have limited treatment options. Its pipeline and commercial programs include candidates such as AXS-05, AXS-12 and AXS-14, addressing disorders including major depressive disorder, Alzheimer’s disease agitation, migraine, narcolepsy and fibromyalgia. Axsome emphasizes innovative mechanisms of action and rigorous clinical development to deliver meaningful improvements in patient outcomes. The company is headquartered in New York City and advances programs through regulatory engagement and commercialization efforts.