Senior Manager, Data Management

The role

The Senior Manager, Clinical Data Management will lead and oversee end-to-end clinical data management activities for assigned clinical studies and programs. This role serves as a lead data manager and subject matter expert to ensure high-quality, inspection-ready data in compliance with regulatory requirements.

What you will do

• Serve as lead Clinical Data Manager and primary point of contact for assigned studies
• Provide oversight of study-level Data Management activities and vendors
• Act as subject matter expert in core Data Management processes
• Oversee DM deliverables and provide leadership for RTSM setup and testing
• Lead translation of protocol requirements into eCRFs and data collection processes
• Mentor and train Data Management staff and cross-functional partners
• Lead Data Management process improvement and standardization initiatives
• Represent data management function in cross-functional and vendor meetings
• Maintain data quality throughout the study lifecycle
• Ensure archival of all Data Management Trial Master File documents

Required qualifications

• Bachelor’s degree
• Minimum of 7 years of clinical data management experience in biotechnology, pharmaceutical, or clinical research organization environment
• At least 3 years serving as the lead data manager for Phase II and Phase III clinical studies
• Demonstrated experience in Electronic Data Capture (EDC) systems development and mid-study change implementation
• Experience with the set-up, configuration review, and user acceptance testing of RTSM, IRT, or IWRS systems
• Strong project management skills
• Strong knowledge of FDA regulations, ICH-GCP guidelines, 21 CFR Part 11 expectations, and industry standards
• Working knowledge of CDISC standards, including CDASH and SDTM concepts
• Ability to work on site Monday, Tuesday & Thursday

Nice to have

• Scientific or healthcare-related degree
• EDC Designer certifications
• Experience with eCOA/ePRO, medical coding, safety systems, data warehouses, and data visualization tools

Benefits

• Annual bonus
• Significant equity
• Generous benefits package

About the company

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. Their neuroscience portfolio includes FDA-approved treatments for major depressive disorder, narcolepsy, and migraine.