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 TMF Specialist that is responsible for supporting clinical document filing and management of Trial Master Files (TMFs).

Reporting into the Sr. Manager, Clinical Systems & TMF Operations, the TMF Specialist ensures that TMFs are current and inspection-ready for internal and external entities.

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 :

• Work closely with the Clinical Study Team to assist in the set-up, review, and maintenance of study specific TMFs in accordance with Standard Operating Procedures (SOPs) and regulatory guidelines
• Collect, review, and index essential documents in accordance with the TMF Structure
• Act as TMF point-of-contact for Study Teams
• Assist with the creation and maintenance of TMF study trackers, including tracking effective and expiration dates of relevant documents
• Provide updates at team meetings of relevant TMF findings and document status as needed
• Conduct TMF quality reviews to ensure accuracy and completeness, and resolves issues as needed with the Clinical Study Team
• Ensure TMF is always inspection ready
• Assist in preparation for and participates in internal or external audits / inspections
• Demonstrate technical and strategic knowledge of applicable regulatory requirements, including applicable specifications, SOPs and ICH / GCP guidelines.

Maintain knowledge of current industry best practices

Requirements / Qualifications

• Bachelor's degree required, preference to candidates with a life science or nursing degree.
• Prior exposure to clinical research
• At least 2 years of experience with electronic trial master file system(s) including uploading, reviewing, QC, and approval of study required documents preferred
• Ability to work on-site Monday, Tuesday, and Thursday. We are unable to consider candidates who are looking for fully remote roles.

Experience and Knowledge

• Knowledge of TMF Reference Model preferred.
• Excellent written and oral communication skills
• Demonstrated experience and ability to manage and prioritize multiple projects
• Computer proficiency, knowledge of GCP and ICH guidelines and other industry regulations required
• Must have good organizational skills, be a team player, function independently, and interact comfortably with company personnel as well as vendors
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities

Salary & Benefits

The anticipated salary range for this role is $80,000-$90,000. 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 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.

Last updated : 2024-05-30

Salary : $80,000 - $90,000