The posting
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 www.axsome.com and follow us on LinkedIn and X.
About This Role
Axsome Therapeutics is seeking a Senior Manager, Clinical Data Management to lead and oversee end-to-end clinical data management activities for assigned clinical studies and programs. This role serves as the lead data manager and a 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 Sr. Manager collaborates cross-functionally with key stakeholders, provides Data Management expertise and leadership throughout study execution, and is accountable for the quality and timely delivery of Data Management milestones from study start-up through database lock and archival. This role is expected to operate independently while providing mentorship to mid-level and junior team members.
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:
- Serve as the lead Clinical Data Manager and primary Data Management point of contact for assigned studies, providing oversight of study-level Data Management activities and vendors, developing timelines, ensuring the timely execution of study activities, and driving the achievement of key deliverables and milestones.
- Act as a subject matter expert in core Data Management processes, including EDC database development, eCRF design, edit check specification development, user acceptance testing, Data Management Plan development, mid-study EDC database changes, data cleaning, external data reconciliation management (including data transfer agreements), and database lock activities.
- Oversee DM deliverables for assigned programs and provide expert leadership for the setup, configuration review, and user acceptance testing of Randomization and Trial Supply Management (RTSM). Ensure alignment with protocol requirements for randomization, stratification, treatment assignment, dosing, and clinical supply management.
- Lead the translation of protocol requirements into fit-for-purpose eCRFs and study-specific data collection processes, and data review tools.
- Mentor and train Data Management staff and cross-functional partners on study-specific processes, Data Management systems, standards, and best practices; may provide line-management support as assigned.
- Lead Data Management process improvement and standardization initiatives in collaboration with Data Management leadership
- Represents data management function in cross-functional team meetings and external vendor meetings, ensuring alignment of expectations, priorities, and deliverables among stakeholders.
- Responsible for maintaining data quality throughout the study lifecycle, including oversight of data reviews, issue resolution, and database lock readiness activities.
- Lead the development and user acceptance testing of Case Report Forms (CRFs) and edit check specifications in accordance with study protocols throughout the study lifecycle.
- Serve as a subject matter expert for Electronic Data Capture (EDC) systems, ensuring accurate translation of protocol requirements into eCRF design, database functionality, and data collection processes.
- 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 other customized data listings, metrics and reports to support medical reviews, clinical reviews, risk-based monitoring and other study oversight activities.
- Ensure archival of all Data Management Trial Master File (TMF) documents to ensure inspection readiness of all Data Management Trial Master File (TMF) documents
Requirements / Qualifications
- Bachelor’s degree required, scientific or healthcare-related degree preferred.
- Minimum of 7 years of clinical data management experience in the biotechnology, pharmaceutical, or clinical research organization environment, including at least 3 years serving as the lead data manager for Phase II and Phase III clinical studies.
- Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles
Experience, Knowledge and Skills
- Demonstrated experience in Electronic Data Capture (EDC) systems development and mid-study change implementation, including leading eCRF design, edit check specification development. EDC Designer certifications a plus.
- Robust knowledge and hands-on experience with the set-up, configuration review, and user acceptance testing of RTSM, IRT, or IWRS systems for clinical trials.
- Strong project management skills, including the ability to develop and manage timelines, prioritize competing deliverables, monitor quality, identify risks, and drive issues to timely resolution.
- Strong knowledge of FDA regulations, ICH-GCP guidelines, 21 CFR Part 11 expectations, and industry standards applicable to clinical data management.
- Experience with eCOA/ePRO, medical coding, safety systems, data warehouses, and data visualization tools is preferred.
- 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, with excellent attention to detail and a consistent 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 across audiences.
- Energetic and motivated self-starter with demonstrated commitment to continuous improvement, innovation, knowledge sharing, and development of team capabilities.
- Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles
Salary & Benefits
The anticipated salary range for this role is $145,000-$160,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.
