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, he or she is owning the timelines of a clinical trial project and is 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 CODL (Clinical Operations Development Lead). The successful candidate will excel in establishing good and effective internal and external working relationships.
REPORTING LINE The Sr. CTM reports to the Clinical Operations Development Lead (CODL)
ROLES AND RESPONSIBILITIES The Sr. CTM is responsible for all clinical operational aspects for the assigned global clinical trial(s) from preparation until closure. The trial responsibilities include:
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
Note: for trials where more than 1 CTM is identified, the tasks will be divided, and so not all CTMs might be involved in all the tasks as listed above. The Sr. CTM will also participate in activities other than trial-related which include but are not limited to:
Provide input to the clinical development strategy/plan
Provide input to procedures/SOPs/WIs and related documents
Participate in workstreams
Ensure best practices and lessons learnt are shared across trials/indications/compounds
Coaching and mentoring other team members
SKILLS AND COMPETENCIES 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)
EDUCATION, EXPERIENCE AND QUALIFICATIONS Bachelors 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
Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at ******. Only inquiries related to an accommodation request will receive a response.
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