PURPOSE OF THE FUNCTION

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

* 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

At argenx we strive to create a welcoming and inclusive environment. ? Here all applicants 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 hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.