Senior, Clinical Trial Manager

Argenx - New York, NY

Full-time - Senior

New York, NY

Administrative and Support Services

About the position

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.

Responsibilities

• Oversee all clinical operational aspects for assigned global clinical trials from preparation until closure.
• Participate and lead clinical trial team meetings with the Lead Trial Physician.
• Oversee risk identification and mitigation for clinical trials, providing solutions and overseeing implementation.
• Ensure clinical trials are executed according to the Clinical Development Plan (CDP), trial plans, and in compliance with argenx procedures, ICH-GCP, and applicable legislation.
• Support and participate in CRO and vendor selection processes.
• Lead CRO contract negotiations with the argenx vendor manager.
• Guide and oversee CROs and other vendors involved in the assigned clinical trial based on metrics and plans.
• Provide input into and develop trial-related materials such as clinical protocols, monitoring plans, and patient information documents.
• Oversee and track patient recruitment, proactively identifying ways to prevent delays.
• Develop monitoring and site oversight strategies and ensure adherence to them.
• Review monitoring visit reports and data listings to ensure reliable quality data delivery and proactively identify issues.
• Ensure the Trial Master File (TMF) is maintained and up to date.
• Ensure timely availability of investigational product supply and maintain clinical site accountability records.
• Ensure timely collection, documentation, and reporting of Adverse Events (AEs) and Serious AEs (SAEs).
• Maintain supportive relationships with clinical sites and trial personnel.
• Clearly communicate goals and motivate team members and vendors to achieve clinical trial goals.
• Proactively identify and solve issues in the assigned clinical trial and escalate them as needed.
• Act as the contact person during inspections/audits for the assigned trial alongside the Quality Assurance representative.
• Identify efficiencies, best practices, and lessons learned, embracing innovation.

Requirements

• Bachelor's degree or University degree in a medical or para-medical field (Biology, Biomedical Sciences, Pharmacy, Veterinary, etc.) or equivalent experience.
• Minimum of 6-7 years of experience in Clinical Operations and managing CROs and vendors.
• Knowledge of ICH-GCP and other applicable legislation for executing clinical trials.
• Experience with tools and systems for managing clinical studies (MS Project, trial progress and metric systems, eCRF databases).

Nice-to-haves

• Biotech experience is a plus.
• Auto-immune and/or oncology clinical trial background is a plus.

Benefits

• Inclusive work environment
• Equal consideration for employment without discrimination
• Opportunities for professional development and growth