Senior, Clinical Trial Manager

Argenx - Dallas, TX

Full-time - Senior

Dallas, TX

Administrative and Support Services

About the position

The Senior Clinical Trial Manager (CTM) is responsible for all operational aspects of the assigned clinical studies from monitoring initiation till closure of the studies. The successful candidate will have clinical trial operational experience in phase I, II, and III drug development phases and is an operational expert in the clinical trial activities from start-up, execution until closure and its underlying activities. The Sr. CTM will be the "operational clinical trial voice" for the assigned studies, both internally and externally, owning the timelines of a clinical trial project and being accountable to keep the trial on track. The Senior Clinical Trial Manager will work with little to no supervision or direction and have the ability to coach junior team members and act as a right hand to the Clinical Operations Development Lead (CODL). The successful candidate will excel in establishing good and effective internal and external working relationships.

Responsibilities

• Participate and lead the clinical trial team meetings together with the Lead Trial Physician.
• Oversee risk identification and mitigations for the clinical trials, provide solutions and oversee implementation.
• Oversee all trial related aspects, timelines, budget and quality.
• Close collaboration with the CODL on changes, issues and potential solutions.
• Ensure that clinical trials are executed according to the Clinical Development Plan (CDP), trial plans, OGSM and in compliance with argenx procedures, ICH-GCP and other applicable legislations.
• Support and participate in CRO and vendor selection.
• Lead CRO contracts negotiations together with the argenx vendor manager.
• Responsible for leading, guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical trial based upon metrics and plan.
• Member of the Country and Site Selection Commission for the specific trial.
• Provide input into and/or develop trial related materials such as clinical protocol, clinical monitoring plans, data management plan, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, patient retention and recruitment materials.
• Oversee and track patient recruitment and pro-actively identifies ways to prevent recruitment delays.
• Develop monitoring and site oversight strategy and oversee adherence to it.
• Perform site oversight visits according to plan.
• Review monitoring visit reports, protocol deviations and data listings to ensure reliable quality data are delivered and proactively identify and solve issues/concerns.
• Monitor data quality.
• Ensure that the Trial Master File (TMF) is maintained and up to date.
• Ensure timely availability of investigational product supply on site and ensure clinical site accountability records on site are in place and maintained.
• Ensure timely collection, documentation and reporting of Adverse events (AEs) and Serious AEs (SAEs) and collaborate in submission of the reports to FDA, EMEA and other applicable regulatory authorities.
• Ensure supportive relationships with clinical sites and trial personnel.
• Clearly communicate on goals/expectations and motivate team members, including vendors, to work towards achieving clinical trial goals.
• Pro-actively identify and solve issues in the assigned clinical trial and timely escalate them to CODL, Head of Trial Operations and/or Senior Management, as needed.
• Responsible and contact person during inspections/audits for the assigned trial together with the Quality Assurance representative.
• Identify efficiencies, best practices and lessons learnt. Search for and embrace innovation.

Requirements

• Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical trial.
• Experience with tools and systems for managing clinical studies (MS project, trial progress and metric systems, eCRF databases).
• Bachelor's degree or University degree - medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience.
• Minimum of 6-7 years of experience in Clinical Operations and managing CROs and vendors.
• Biotech experience is a plus.
• Auto-immune and/or oncology clinical trial background is a plus.