Clinical Trial Manager/Senior Clinical Trial Manager

About the role

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.

About This Role

Axsome Therapeutics is seeking a Clinical Trial Manager/Senior Clinical Trial Manager who will be the primary operational lead for a study and will lead the cross-functional team for execution of the study.

The Clinical Trial Manager/Senior Clinical Trial Manager provides operational leadership to the study team to ensure project milestones deliver on time, within budget, high quality, and in compliance with the ICH / GCP, regulatory authority's regulations/guidelines, and applicable SOPs.

This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the program director when needed.

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:

• Responsible for leading all operational aspects and progress of clinical trial which can include but is not limited to: study planning activities; study execution including ongoing tracking of all applicable performance metrics; and quality indicators
• Serve as an escalation point and resource for study team and investigative sites
• Facilitate and review the site feasibility process and oversee the site selection processes
• Oversee subject recruitment / retention strategy and related initiatives
• Provide operational input for study documents such as synopsis, and protocol, and develops/approves ICFs, CRFs, CRF Completion Guidelines, study plans, including Clinical Monitoring Plan, Protocol Deviation Plan, Risk Management Plan, etc.
• Develop protocol training materials for CRAs and site-facing materials for SEVs, SIVs and ad-hoc training
• Responsible for oversight of study teams in review of clinical data in conjunction with Data Management; provides guidance on issues / queries as needed and implements risk management concepts as appropriate
• In conjunction with the Lead CRA, this position will be responsible for motivating and leading the assigned clinical monitoring team to deliver on study timelines and milestone deliverables
• Oversee monitoring visit schedule to ensure compliance with frequency set forth in CMP
• Review site monitoring visit reports for clarity and completeness and escalates issues identified
• Participate in clinical vendor selection process as a part of outsourcing activities
• Assist in the review and approval of vendor and site budgets along with the study director
• Provide oversight for all clinical vendor activities (e.g.,, specifications development, UATs, issues escalations, KPIs)
• Work closely with QA to drive CAPA review, implementation, and completion
• Oversee the eTMF set-up, ongoing quality review, and final reconciliation of study documents
• Ensure that all aspects of GCP compliance and audit/inspection readiness are maintained throughout trial conduct
• Create, manage, measure, and report timelines for milestone deliverables
• Proactively manage and identify potential study issues and risks as well as recommend and implement solutions with key internal / external 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 / Qualifications

• Bachelor's degree required; preference to candidates with a scientific background
• At least 5 years clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO) for Clinical Trial Manager level
• At least 7 years clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO) for Senior Clinical Trial Manager level
• Preference to candidates with prior small company experience and 1+ years management 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

• Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations / ICH / GCP guidelines, is required
• Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies that lead to obtaining results
• Strong attention to detail, time management and excellent organizational skills
• Strong interpersonal skills and communication skills (both written and oral)
• Ability to problem solve, delegate appropriate tasks, work within a team environment and mentor junior team members such as CTAs/CRAs.
• 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 and able to adjust workload based upon changing priorities
• Preference to energetic candidates with a desire to think "outside the box"
• Willingness to travel as needed, up to 20%

Salary and Benefits

The anticipated salary range for this role is $130,000 - $150,000. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

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.