Clinical Trial Manager

$120,000 - $140,000/Yr

Axsome Therapeutics - New York, NY

Full-time - Mid Level

Remote - New York, NY

Professional, Scientific, and Technical Services

About the position

Axsome Therapeutics is seeking a 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 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. The Clinical Trial Manager will be responsible for leading all operational aspects and progress of clinical trials, which can include but is not limited to: study planning activities; study execution including ongoing tracking of all applicable performance metrics; and quality indicators. The role also involves serving as an escalation point and resource for the study team and investigative sites, facilitating and reviewing the site feasibility process, overseeing subject recruitment and retention strategies, and providing operational input for study documents such as synopsis and protocol. Additionally, the Clinical Trial Manager will develop protocol training materials for CRAs and site-facing materials for SEVs, SIVs, and ad-hoc training. They will oversee monitoring visit schedules to ensure compliance with frequency set forth in the Clinical Monitoring Plan (CMP) and review site monitoring visit reports for clarity and completeness. The position also includes participation in the clinical vendor selection process, assisting in the review and approval of vendor and site budgets, and providing oversight for all clinical vendor activities. The Clinical Trial Manager will work closely with QA to drive CAPA review, implementation, and completion, ensuring that all aspects of GCP compliance and audit/inspection readiness are maintained throughout trial conduct. The role requires proactive management and identification of potential study issues and risks, recommending and implementing solutions with key internal and external stakeholders. The Clinical Trial Manager will lead internal team meetings and participate in the development, review, and implementation of departmental SOPs, initiatives, and processes. They may also conduct Site Evaluation visits (SEVs) and Site Initiation Visits (SIVs), review and approve vendor invoices for all clinical trial vendors, and take on additional responsibilities as assigned.

Responsibilities

• Lead all operational aspects and progress of clinical trials including study planning and execution.
• 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 and retention strategy and related initiatives.
• Provide operational input for study documents such as synopsis and protocol, and develop/approve ICFs, CRFs, and study plans.
• Develop protocol training materials for CRAs and site-facing materials for SEVs, SIVs, and ad-hoc training.
• Oversee monitoring visit schedule to ensure compliance with frequency set forth in CMP.
• Review site monitoring visit reports for clarity and completeness and escalate issues identified.
• Participate in clinical vendor selection process as 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 including specifications development and 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 and recommend solutions.
• Lead internal team meetings and other trial-specific meetings.
• Participate in the 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

• 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).
• Preference to candidates with prior small company experience and 1+ years management experience.
• 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 within generally defined practices and policies.
• 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 and able to adjust workload based upon changing priorities.

Nice-to-haves

• Energetic candidates with a desire to think 'outside the box'.

Benefits

• Competitive salary range of $120,000 - $140,000.
• Annual bonus.
• Significant equity.
• Generous benefits package.