Associate, TMF Documentation

Role: Associate, TMF Documentation at Axsome Therapeutics, supporting clinical document management to ensure TMFs are inspection-ready. Responsibilities: assist in review, maintenance, and indexing of study-specific TMFs; update TMF trackers; participate in audits and inspections; ensure compliance with SOPs, ICH/GCP, and regulatory standards; maintain industry best practices. Requirements: Bachelor’s degree, preferably in life sciences or nursing; 6 months to 1 year relevant experience; familiarity with electronic TMF systems and reference models preferred; excellent communication skills. High-Value: clinical trials, TMF management, regulatory compliance, GxP standards, audit readiness, CNS therapeutic focus. WorkSetup: onsite in New York City, 3 days per week; no remote options.