Argenx - New York, NY
posted 3 months ago
The Senior Clinical Trial Manager (CTM) at argenx is tasked with overseeing all operational aspects of assigned clinical studies from initiation through to closure. This role requires a candidate with extensive clinical trial operational experience across phase I, II, and III drug development phases. The Sr. CTM serves as the operational voice for the assigned studies, ensuring that timelines are adhered to and that the trials remain on track. The successful candidate will work independently, demonstrating the ability to coach junior team members and support the Clinical Operations Development Lead (CODL). Establishing effective internal and external relationships is crucial for success in this role. The responsibilities of the Sr. CTM encompass a wide range of activities, including leading clinical trial team meetings alongside the Lead Trial Physician, overseeing risk identification and mitigation strategies, and ensuring that clinical trials are executed in compliance with the Clinical Development Plan (CDP) and relevant regulations. The Sr. CTM will also be involved in the selection of Contract Research Organizations (CROs) and vendors, leading contract negotiations, and guiding CROs based on established metrics and plans. Additionally, the Sr. CTM will provide input into trial-related materials and oversee patient recruitment strategies to prevent delays. The role also includes monitoring data quality, maintaining the Trial Master File (TMF), ensuring the timely collection and reporting of adverse events, and fostering supportive relationships with clinical sites. The Sr. CTM will communicate goals and expectations clearly to motivate team members and vendors, proactively identifying and resolving issues as they arise. Furthermore, the Sr. CTM will participate in activities beyond trial management, contributing to clinical development strategies and mentoring other team members. This position is integral to the success of argenx's mission to transform immunology and deliver innovative medicines to patients with autoimmune diseases.