Specialist/Senior Specialist

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 Specialist/Senior Specialist, Clinical Data Management support clinical data management activities in compliance with ICH GCP, regulatory guidelines/standards and applicable SOPs. This role supports lead data managers, clinical trial managers (CTMs), clinical research associates (CRAs), and clinical trial associates (CTAs) in all data management related activities (i.e. data review and data entries) across multiple programs. The Specialist/Senior Specialist, Clinical Data Management may also serve as the lead clinical data manager or program lead. This role will report to the Senior Manager, 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:

• Support Data Management oversight of multiple clinical development programs
• Serve as primary liaison for Data Management vendor for assigned studies as well as primary resource for study team and monitors
• Support the planning and management of data Management timelines
• Represent Data Management function on the clinical team meetings ensuring aligned expectations between the vendor and Axsome
• Create and maintain study data cleaning trackers
• Ensure achievement of major Data Management deliverables and milestones in coordination with other functions including Clinical Operations, Safety, Statistics, etc.
• Maintain all Data Management documentation to ensure inspection readiness of all Data Management Trial Master File (TMF) documents
• Draft/review Data Management Plans, data entry guidelines, Data Management reports, validation plans, lab reconciliations and other DM and study specific documents
• Support the development of Case Report Forms (CRFs) and edit checks per protocol and performs user acceptance testing of CRFs and co-develops associated edit check specifications as required
• Assist in preparing clean databases by performing reviews of clinical trial data through electronic data capture (EDC) and/or data listings
• Generate queries, data listings, metrics, quality reports to appropriate internal or external personnel (i.e. investigational sites, vendors, Clinical Research Associates) to assist in overseeing quality and 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
• Generate custom safety listings and presents to Medical Monitor and study team
• Gather metrics to support risk-based monitoring
• Responsible for training of Clinical Trial Associates (CTAs)/Clinical Program Coordinators (CPCs) on data management activities

Requirements / Qualifications

• Bachelor’s degree required. Preference to candidates with a life science degree
• At least 2 years’ data management experience in a biotech/pharmaceutical company or clinical research organization (CRO), or clinical research site with Data Management focus or related duties
• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles

Experience and Knowledge

• Good understanding of FDA, GCP and ICH guidelines
• Experience with electronic data capture (EDC) systems/technologies as applied to clinical trials
• Good working knowledge of (e)CRF design and data management functions/activities
• Good working knowledge of Microsoft Office software and apps with strong knowledge of Excel. A plus if proficient with data visualizations and database concepts
• Ability to handle multiple clinicalprograms simultaneously
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
• Preference to strong work ethic, energetic candidates with a desire to think “outside the box”
• Strong attention to detail, time management, and excellent organizational skills

Salary and Benefits:

The anticipated salary range for this role is $80,000 - $100,000. 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.