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, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates 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 Clinical Trial Associate (CTA) that is responsible for supporting the organization to successfully develop and implement clinical trials across its product portfolio and development pipeline. This role provides support to the Clinical Trial Manager (CTM), field based Clinical Research Associates (CRAs), and clinical study sites. This role will be a key study team member responsible for contributing to the life cycle of a clinical trial (all phases) and assure compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
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:
- Create and maintain study trackers (e.g., contact lists, study status trackers, study specific checklists.)
- Ensure accurate and up to date information in clinical trial management system (CTMS)
- Review and maintain documents in the Electronic Trial Master File (eTMF)
- Assist clinical study team during all phases of clinical trial activities (e.g., feasibility, start-up, maintenance, and close-out)
- Collect and review clinical study site essential regulatory documents prior to site initiation/study drug release
- Submission and tracking of documents to central/local Institutional Review Board (IRB)
- Distribute study materials to clinical study sites, as directed
- Participate in meetings with internal and external stakeholders, draft meeting agendas and minutes, as needed
- Assist the clinical study team in preparation and distribution of study documents and materials (e.g., informed consent form, regulatory binder, patient recruitment materials, and newsletters)
- Support field-based CRAs
- Assist data management with review of clinical data as needed
- Assist clinical study team with the final reconciliation of the eTMF during study close-out
Requirements / Qualifications
- Bachelor’s degree required. Preference to candidates with a life science degree
- Minimum 1 year of relevant experience
- Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles.
Experience and Knowledge
- Must have good organizational skills, be a team player, function independently, and be able to interact comfortably with colleagues and external stakeholders (e.g., study vendors, clinical study sites).
- Basic understanding of ICH/GCP and clinical research terminology preferred
- Comfortable multi-tasking in a fast-paced small company environment and able to adjust priorities as needed
- Excellent team player; willingness and ability to fill functional gaps in a small but growing organization
- Additional skills/qualifications for the role, including any that are preferred but not required
Salary and Benefits:
The anticipated salary range for this role is $60,000 - $68,000. 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.
