Senior Clinical Data Manager — Onsite Lead

Axsome Therapeutics, Inc.; New York (NY); On-site; USD 145,000 - 160,000; Full time

Benefits offered by this job

Annual bonus

Equity

Generous benefits package

Job summary

Axsome Therapeutics, Inc. in New York City is seeking a Senior Manager, Clinical Data Management to lead end-to-end DM activities for major CNS programs.

You will oversee data management processes, collaborate cross-functionally, and ensure inspection-ready data from study start-up to database lock. The role requires on-site presence at least three days per week at our NYC HQ, with a focus on high data quality, regulatory compliance, and team mentorship.

Qualifications

• Bachelor’s degree; scientific or healthcare-related preferred.

Responsibilities

• Serve as lead Clinical Data Manager for assigned studies, overseeing DM activities and vendors.
• Act as SME in data management processes including EDC design, edit checks, DMPs, and data cleaning.
• Oversee RTSM setup, configuration review, and UAT to ensure protocol alignment.
• Translate protocol requirements into fit-for-purpose eCRFs and data collection processes.
• Mentor Data Management staff and partners on processes and systems.
• Lead DM process improvements and standardization with DM leadership.
• Represent DM in cross-functional and vendor meetings to align expectations and deliverables.
• Ensure data quality across study lifecycle and readiness for database lock.

Skills

EDC systems

RTSM/IRT/IWRS

Project management

FDA/ICH-GCP familiarity

eCOA/ePRO

CDISC (CDASH/SDTM)

Data quality improvement

Leadership/mentoring

Education

Bachelor's degree

Tools

EDC systems

Job description

Axsome Therapeutics, Inc. in New York City is seeking a Senior Manager, Clinical Data Management to lead end-to-end DM activities for major CNS programs.

You will oversee data management processes, collaborate cross-functionally, and ensure inspection-ready data from study start-up to database lock. The role requires on-site presence at least three days per week at our NYC HQ, with a focus on high data quality, regulatory compliance, and team mentorship.