Remote opportunity at
Axsome Therapeutics, Inc.Senior Manager, Data Management
Axsome Therapeutics, Inc., a biopharmaceutical company concentrating on central nervous system disorders, seeks a Senior Manager, Clinical Data Management. The organization develops neuroscience treatments spanning FDA-approved…
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About This Role
Axsome Therapeutics, Inc., a biopharmaceutical company concentrating on central nervous system disorders, seeks a Senior Manager, Clinical Data Management. The organization develops neuroscience treatments spanning FDA-approved medications and late-stage programs for serious psychiatric and neurological conditions. This position takes charge of end-to-end clinical data management tasks for assigned clinical studies and programs. Operating as a lead data manager and subject matter expert, the person in this role guarantees inspection-ready, high-quality…
Job Description
Axsome Therapeutics, Inc., a biopharmaceutical company concentrating on central nervous system disorders, seeks a Senior Manager, Clinical Data Management. The organization develops neuroscience treatments spanning FDA-approved medications and late-stage programs for serious psychiatric and neurological conditions.
This position takes charge of end-to-end clinical data management tasks for assigned clinical studies and programs. Operating as a lead data manager and subject matter expert, the person in this role guarantees inspection-ready, high-quality data that adheres to ICH-GCP guidelines, industry standards, and internal procedures. Responsibilities include managing vendors, establishing timelines, driving milestones from start-up to database lock, and collaborating with cross-functional partners while mentoring junior staff members.
The position requires working on-site at the company headquarters in New York City on Mondays, Tuesdays, and Thursdays, and cannot accommodate fully remote applicants.
Responsibilities
- Serve as the lead Clinical Data Manager and primary contact for assigned studies to oversee data management activities and vendors
- Establish timelines and drive the execution of study activities and deliverables
- Act as a subject matter expert in core data management procedures such as EDC database development, eCRF design, edit check specifications, and user acceptance testing
- Oversee program-level deliverables and manage setup, configuration reviews, and user acceptance testing for RTSM
- Translate protocol requirements into eCRFs, data collection processes, and data review tools
- Maintain data quality throughout the study lifecycle via data reviews, issue resolution, and database lock preparation
- Manage external data transfers, reconciliations, and system integrations
- Draft and maintain Data Management Plans, data entry guidelines, and study reports
- Ensure the archival of all Data Management Trial Master File documents for inspection readiness
Requirements
- Bachelor's degree
- Minimum of 7 years of clinical data management experience within pharmaceutical, biotechnology, or clinical research organization settings
- At least 3 years of experience serving as a lead data manager for Phase II and Phase III clinical studies
- Demonstrated experience in electronic data capture systems development and mid-study change implementation
- Hands-on experience with the set-up, configuration review, and user acceptance testing of RTSM, IRT, or IWRS systems
- Working knowledge of FDA regulations, ICH-GCP guidelines, and 21 CFR Part 11 expectations
Qualifications
- Scientific or healthcare-related degree
- EDC Designer certifications
- Experience with eCOA/ePRO, medical coding, safety systems, data warehouses, and data visualization tools
- Working knowledge of CDISC standards including CDASH and SDTM concepts
Core Skills
Benefits
- Annual bonus
- Significant equity
- Generous benefits package
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the salary range for this position?
The anticipated salary range is between $145,000 and $160,000 per year, with the final offer depending on experience, qualifications, internal equity, and location.
Is this a remote position?
No, this role is not fully remote. It is based at the company headquarters in New York City with a mandatory on-site presence on Mondays, Tuesdays, and Thursdays.
What level of experience is required?
Candidates must hold a bachelor's degree and have at least 7 years of clinical data management experience in biotech, pharma, or CRO environments, including a minimum of 3 years as a lead data manager for Phase II and III studies.
What additional compensation is included besides base salary?
The employment package includes an annual bonus, significant equity, and a generous benefits package.
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