Clinical Trial Manager​/Senior Clinical Trial Manager

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States.

Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at and follow us on Linked In and X.

Axsome Therapeutics is seeking a Clinical Trial Manager/Senior Clinical Trial Manager who will be the primary operational lead for a study and will lead the cross-functional team for execution of the study. The Clinical Trial Manager/Senior Clinical Trial Manager provides operational leadership to the study team to ensure project milestones deliver on time, within budget, high quality, and in compliance with the ICH / GCP, regulatory authority’s regulations/guidelines, and applicable SOPs.This

position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the program director when needed.

This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.

• Responsible for leading all operational aspects and progress of clinical trial which can include but is not limited to: study planning activities; study execution including ongoing tracking of all applicable performance metrics; and quality indicators
• Serve as an escalation point and resource for study team and investigative sites
• Facilitate and review the site feasibility process and oversee the site selection processes
• Oversee subject recruitment / retention strategy and related initiatives
• Provide operational input for study documents such as synopsis, and protocol, and develops/approves ICFs, CRFs, CRF Completion Guidelines, study plans, including Clinical Monitoring Plan, Protocol Deviation Plan, Risk Management Plan, etc.
• Develop protocol training materials for CRAs and site-facing materials for SEVs, SIVs and ad-hoc training
• Responsible for oversight of study teams in review of clinical data in conjunction with Data Management; provides guidance on issues / queries as needed and implements risk management concepts as appropriate
• In conjunction with the Lead CRA, this position will be responsible for motivating and leading the assigned clinical monitoring team to deliver on study timelines and milestone deliverables
• Oversee monitoring visit schedule to ensure compliance with frequency set forth in CMP
• Review site monitoring visit reports for clarity and completeness and escalates issues identified
• Participate in clinical vendor selection process as a part of outsourcing activities
• Assist in the review and approval of vendor and site budgets along with the study director
• Provide oversight for all clinical vendor activities (e.g.,, specifications development, UATs, issues escalations, KPIs)
• Work closely with QA to drive CAPA review, implementation, and completion
• Oversee the eTMF set-up, ongoing quality review, and final reconciliation of study…