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About the Role

Axsome Therapeutics is seeking a Clinical Trial Manager/Senior Clinical Trial Manager to serve as the primary operational lead for a study, guiding a cross-functional team for its execution. This role ensures project milestones are met on time, within budget, and with high quality, adhering to ICH/GCP, regulatory guidelines, and SOPs. The position requires independent management of duties with guidance from the program director when necessary.

Responsibilities

Lead all operational aspects and progress of clinical trials, including study planning, execution, and tracking of performance metrics and quality indicators.
Act as an escalation point and resource for study teams and investigative sites.
Facilitate and review site feasibility and oversee site selection processes.
Oversee subject recruitment and retention strategies and initiatives.
Provide operational input for study documents (e.g., synopsis, protocol) and develop/approve ICFs, CRFs, CRF Completion Guidelines, and study plans (e.g., Clinical Monitoring Plan, Protocol Deviation Plan, Risk Management Plan).
Develop protocol training materials for CRAs and site-facing materials for SEVs, SIVs, and ad-hoc training.
Oversee study teams in reviewing clinical data with Data Management, providing guidance on issues/queries and implementing risk management concepts.
Motivate and lead the clinical monitoring team to meet study timelines and deliverables.
Oversee monitoring visit schedules to ensure compliance with the CMP.
Review site monitoring visit reports for clarity and completeness, escalating identified issues.
Participate in the clinical vendor selection process for outsourcing activities.
Assist in the review and approval of vendor and site budgets with the study director.
Provide oversight for all clinical vendor activities, including specifications development, UATs, issue escalations, and KPIs.
Work closely with QA to drive CAPA review, implementation, and completion.
Oversee eTMF set-up, ongoing quality review, and final reconciliation of study documents.
Ensure GCP compliance and audit/inspection readiness throughout trial conduct.
Create, manage, measure, and report timelines for milestone deliverables.
Proactively manage and identify potential study issues and risks, recommending and implementing solutions with stakeholders.
Lead internal team meetings and other trial-specific meetings.
Participate in the development, review, and implementation of departmental SOPs, initiatives, and processes.
May conduct Site Evaluation Visits (SEVs) and Site Initiation Visits (SIVs).
Review and approve vendor invoices for all clinical trial vendors, including investigative sites.

Requirements

Bachelor's degree required; preference for candidates with a scientific background.
At least 5 years of clinical research experience in a biotech/pharmaceutical company or CRO for Clinical Trial Manager level.
At least 7 years of clinical research experience in a biotech/pharmaceutical company or CRO for Senior Clinical Trial Manager level.
Preference for candidates with prior small company experience and 1+ years of management experience.
Ability to work on site Monday, Tuesday & Thursday.
Willingness to travel as needed, up to 20%.

Skills

Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations / ICH / GCP guidelines.
Ability to work on complex or multiple projects and exercise independent judgment.
Strong attention to detail, time management, and excellent organizational skills.
Strong interpersonal and communication skills (both written and oral).
Ability to problem-solve, delegate appropriate tasks, work within a team environment, and mentor junior team members.
Excellent sense of urgency to deliver at/surpass study conduct targets.
Strong leadership skills.
Self-motivated.
Adaptable to a dynamic environment.
Comfortable multi-tasking in a fast-paced small company environment.
Able to adjust workload based upon changing priorities.
Energetic candidates with a desire to think “outside the box” are preferred.

Location

New York City, NY
On-site (at least three days per week)

Work Type

On-site
Full-time

Experience Level

Clinical Trial Manager
Senior Clinical Trial Manager
1+ years management experience

Education Level

Bachelor's degree

Salary/Compensations

$130,000 - $150,000

Benefits

Annual bonus
Significant equity
Generous benefits package

About the Company

Axsome Therapeutics is a biopharmaceutical company focused on treating 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.
Our 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.
We have multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions impacting over 150 million people in the United States.
Our mission is to solve some of the brain’s biggest problems so patients and their loved ones can flourish.

Equal Opportunity

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.