Senior Manager, Data Management

Axsome Therapeutics•New York, NY

4h•$145,000 - $160,000•Hybrid

About The Position

Axsome Therapeutics is seeking a Senior Manager, Clinical Data Management to lead end-to-end clinical data management activities for assigned clinical studies and programs. The role serves as the lead data manager and subject matter expert in core Data Management processes, ensuring high-quality, timely, inspection-ready data in compliance with ICH-GCP, applicable regulatory requirements, industry standards, and company procedures. The Senior Manager collaborates with cross-functional stakeholders, provides Data Management expertise and leadership throughout study execution, and is accountable for quality and timely delivery of Data Management milestones from study start-up through database lock and archival. The position operates independently and provides mentorship to mid-level and junior team members. The role is based at Axsome’s New York City headquarters and requires on-site work at least three days per week, specifically Monday, Tuesday, and Thursday. Fully remote candidates will not be considered. The anticipated salary range is $145,000–$160,000, with possible flexibility in final job title and responsibilities. Compensation depends on factors including experience, qualifications, internal equity, and location. The employment package includes an annual bonus, significant equity, and a benefits package.

Requirements

Bachelor’s degree required; a scientific or healthcare-related degree is preferred.
At least 7 years of clinical data management experience in a biotechnology, pharmaceutical, or clinical research organization environment.
At least 3 years serving as lead data manager for Phase II and Phase III clinical studies.
Demonstrated experience developing EDC systems and implementing mid-study changes, including leading eCRF design and edit check specification development.
Hands-on experience with setup, configuration review, and user acceptance testing of RTSM, IRT, or IWRS systems for clinical trials.
Strong project management skills, including developing and managing timelines, prioritizing deliverables, monitoring quality, identifying risks, and resolving issues promptly.
Strong knowledge of FDA regulations, ICH-GCP guidelines, 21 CFR Part 11 expectations, and industry standards applicable to clinical data management.
Working knowledge of CDISC standards, including CDASH and SDTM concepts, and experience applying data standards to clinical study design and execution.
Strong analytical, problem-solving, organizational, and decision-making skills, attention to detail, and focus on data quality.
Ability to manage multiple studies and priorities in a fast-paced environment while maintaining accountability for timelines, quality, and regulatory compliance.
Excellent written and verbal communication skills and a collaborative, solutions-oriented leadership style; ability to communicate technical concepts to different audiences.
Self-motivation and commitment to continuous improvement, innovation, knowledge sharing, and developing team capabilities.
Ability to work on site Monday, Tuesday, and Thursday; fully remote work is not available.

Nice To Haves

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

Responsibilities

Serve as lead Clinical Data Manager and primary Data Management contact for assigned studies, overseeing study-level activities and vendors, developing timelines, and ensuring timely execution of activities and milestones.
Provide subject matter expertise in core Data Management processes, including EDC database development, eCRF design, edit check specifications, user acceptance testing, Data Management Plans, mid-study EDC changes, data cleaning, external data reconciliation, data transfer agreements, and database lock activities.
Oversee Data Management deliverables and lead setup, configuration review, and user acceptance testing of RTSM, ensuring alignment with protocol requirements for randomization, stratification, treatment assignment, dosing, and clinical supply management.
Translate protocol requirements into fit-for-purpose eCRFs, study-specific data collection processes, and data review tools.
Mentor and train Data Management staff and cross-functional partners on study-specific processes, systems, standards, and best practices; provide line-management support as assigned.
Lead Data Management process improvement and standardization initiatives with Data Management leadership.
Represent Data Management in cross-functional and external vendor meetings, aligning stakeholder expectations, priorities, and deliverables.
Maintain data quality throughout the study lifecycle through oversight of data reviews, issue resolution, and database lock readiness activities.
Lead development and user acceptance testing of CRFs and edit check specifications in accordance with study protocols throughout the study lifecycle.
Manage external data transfers, reconciliations, and system integrations to ensure data integrity and completeness.
Draft, review, and maintain Data Management Plans, data entry guidelines, Data Management reports, and other study-related documents.
Develop and maintain safety and customized data listings, metrics, and reports for medical and clinical reviews, risk-based monitoring, and other study oversight activities.
Ensure archival of all Data Management Trial Master File documents to support inspection readiness.