Manager, Clinical Data Management

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  and follow us on Linked In and X.

About This Role

Axsome Therapeutics is seeking a Manager, Data Management to be responsible for conducting and overseeing all data management aspects for assigned clinical program(s) in compliance with ICH GCP, regulatory guidelines/standards and applicable SOPs. Tasks include collaborating cross-functionally with study teams, providing DM expertise and conducting all data management activities, overseeing vendors, timelines, costs, resources, and key project deliverables.

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:

* Data management oversight of multiple clinical development programs in addition to serving as the lead clinical data manager on designated programs as needed

* Responsible for data related vendor selection and oversight activities across multiple clinical development programs

* Oversee the planning and management of Data Management costs and timelines

* Represent data management function on the clinical and cross-functional team meetings ensuring aligned expectations between all parties, including outside vendors.

* Ensure achievement of major data management deliverables and milestones in coordination with other functions including Clinical Operations, Safety, Statistics, etc.

* Responsible for drafting safety and other customized data listings/metrics/reports to drive activities such as medical reviews, clinical reviews and risk-based monitoring

* Participate and represent data management function in during audits and inspections as requested.

* Author, review, and revise Standard Operating Procedures (SOPs)

* Draft/review Data Management Plans, data entry guidelines, data management reports and other documents

* Lead the development and user acceptance testing of Case Report Forms (CRFs) and edit check specifications per protocol, across the lifecycle of the study

* Manage external data transfers, reconciliations, and system integrations

* Lead the process of cleaning databases by performing a review of clinical trial data through EDC or data listings

* Generate queries to appropriate internal or external personnel (e.g.

- investigational sites, vendors, Clinical Research Associates) to resolve problematic data identified during every aspect of the data management process

* Review responses to queries for appropriateness and resolution to ensure high data quality

* Train team members on Axsome procedures, study specific handling and management of Data Management systems

* May also act to supervise and mentor data management staff

* Ensure archival of all Data Management Trial Master File (TMF) documents

Requirements / Qualifications

* Bachelor's degree required. Preference to candidates with a scientific background (RN, MS, MD, Pharm

D, PhD or similar)

* Minimum of 4 - 7 years data management experience in a biotech/pharmaceutical company or clinical research organization (CRO)

* Thorough understanding of FDA, GCP and ICH guidelines

* Strong knowledge of EDC and/or systems design (i.e., Merative Zelta (IBM Clinical), Veeva, Medrio, Rave, etc.), IRT/IWRS and data warehouse…