Manager, Clinical Data Management

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

About This Role:

Axsome Therapeutics is seeking a Manager, Clinical Data Management responsible for conducting and overseeing all data management aspects for assigned clinical program(s) in compliance with ICH GCP, regulatory guidelines/standards and applicable SOPs. Tasks include collaborating cross-functionally with study teams, providing Data Management (DM) expertise and conducting all Data Management activities, overseeing vendors, timelines, costs, resources, and key project deliverables. This position will report to the Senior Director, Clinical Data Management.  

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:

• Data Management (DM) oversight of multiple clinical development programs in addition to serving as the lead Clinical Data Manager on designated programs as needed 
• Responsible for data related vendor selection and oversight activities across multiple clinical development programs 
• Oversee the planning and management of Data Management costs and timelines 
• Represent data management function in clinical and cross-functional team meetings, ensuring aligned expectations between all parties, including outside vendors 
• Ensure achievement of major Data Management deliverables and milestones in coordination with other functions including Clinical Operations, Safety, Statistics, etc. 
• Responsible for drafting safety and other customized data listings, metrics, and reports to drive activities such as medical reviews, clinical reviews, and risk-based monitoring 
• Participate and represent data management function during audits and inspections, as requested 
• Author, review, and revise Standard Operating Procedures (SOPs) 
• Draft and review Data Management Plans, data entry guidelines, Data Management reports and other documents 
• Lead the development and user acceptance testing of Case Report Forms (CRFs) and edit check specifications per protocol, across the lifecycle of the study 
• Manage external data transfers, reconciliations, and system integrations 
• Lead the process of cleaning databases by performing a review of clinical trial data through EDC or data listings 
• Generate queries to appropriate internal or external personnel (i.e. investigational sites, vendors, Clinical Research Associates) to resolve problematic data identified during every aspect of the data management process 
• Review responses to queries for appropriateness and resolution to ensure high data quality 
• Train team members on Axsome procedures, study specific handling and management of Data Management systems 
• Mentor data management and cross functional staff on data management processes 
• Ensure archival of all Data Management Trial Master File (TMF) documents 

Requirements / Qualifications

• Bachelor’s degree required. Preference to candidates with a scientific background (RN, MS, MD, PharmD, PhD or similar) 
• 5-7 years data management experience in a biotech/pharmaceutical company, or clinical research organization (CRO) 
• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles 

Experience and Knowledge:

• Thorough understanding of FDA, GCP and ICH guidelines 
• Strong knowledge of EDC and/or systems design (i.e., Merative Zelta (IBM Clinical), Veeva, Medrio, Rave, etc.), Interactive Response Technology (IRT)/Interactive Web Response Systems (IWRS) and data warehouse technologies as applied to clinical trials
• Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance
• Good working knowledge of Clinical Data Interchange Standards Consortium (CDISC) standards and experience implementing standards preferred
• Advanced knowledge of Excel
• Good working knowledge of general statistical programming processes and practices. Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, and clinical procedures
• Exhibits initiative, strong problem solving, and leadership skills
• Ability to handle multiple programs simultaneously with strong project management capabilities
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
• Excellent team player: willingness and ability to fill functional gaps in a small but growing organization
• Strong attention to detail and excellent organization skills
• Strong interpersonal skills and communication skills (both written and oral)
• Embody a culture of continual improvement and innovation; promote knowledge sharing 

Salary and Benefits:

The anticipated salary range for this role is $115,000 - $130,000. 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.