Clinical Trial Manager/Senior Clinical Trial Manager

Axsome Therapeutics is seeking a Clinical Trial Manager/Senior Clinical Trial Manager as the primary operational lead for clinical studies. This role is based at Axsome’s HQ in New York City with an on‑site requirement of at least three days per week. Job Responsibilities and Duties Lead all operational aspects and progress of clinical trials, including study planning, execution, and progress tracking. Serve as escalation point and resource for the study team and investigative sites. Facilitate and review site feasibility and oversee site selection processes. Oversee subject recruitment and retention strategy. Provide operational input for study documents such as synopsis, protocol, ICFs, CRFs, and develop approval plans (CMPlan, PDP, RMP). Develop protocol training materials for CRAs and site‑facing materials for SEVs, SIVs, and ad‑hoc training. Coordinate with data management to review clinical data, provide guidance, and implement risk‑management concepts. Motivate and lead the clinical monitoring team to deliver on study timelines and milestones. Oversee the monitoring visit schedule and review site monitoring visit reports for clarity and completeness. Participate in vendor selection and review/approval of vendor and site budgets. Provide oversight of clinical vendor activities, including specifications, UATs, issue escalation, 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 potential study issues and risks, recommend and implement solutions. Lead internal team meetings and other trial‑specific meetings. Participate in development, review, and implementation of departmental SOPs, initiatives, and processes. Conduct site evaluation visits (SEVs) and site initiation visits (SIVs) as needed. Review and approve vendor invoices for all clinical trial vendors. Requirements / Qualifications Bachelor’s degree required; preference for candidates with a scientific background. At least 5 years of clinical research experience for a Clinical Trial Manager level; at least 7 years for a Senior Clinical Trial Manager level. Preference for candidates with prior small‑company experience and at least 1 year of management experience. Ability to work on site Monday, Tuesday & Thursday; fully remote candidates will not be considered. Experience and Knowledge Knowledge of clinical research operations, FDA regulations, ICH/GCP guidelines. Ability to manage complex or multiple projects with independent judgment. Strong attention to detail, time management, and organizational skills. Excellent written and oral communication and interpersonal skills. Capability to delegate, mentor junior team members, and work in a team environment. Strong sense of urgency to meet or exceed study conduct targets. Self‑motivated leadership skills and adaptability to a dynamic environment. Comfortable with multi‑tasking in a fast‑paced small‑company setting. Willingness to travel up to 20 %. Salary and Benefits The anticipated salary range is $130,000 – $150,000. The compensation package may include an annual bonus; equity and a generous benefits package are also offered. Equal Employment Opportunity Statement 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, disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. #J-18808-Ljbffr