Axsome Therapeutics - New York, NY
posted 5 months ago
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.