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, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs 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 www.axsome.com and follow us on LinkedIn and X.

About This Role:

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.   

Job Responsibilities and Duties include, but are not limited to, the following:

• 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, st