Company : Argenx Location : Ghent Flanders From : Talent BE
The successful candidate will excel in establishing good and effective internal and external working relationships.Reporting lineThe CTM reports to the Clinical Operations Development Lead (CODL)Roles & ResponsibilitiesThe CTM is responsible for all clinical operational aspects for the assigned global clinicaltrial(s) from preparation until closure.
The trial responsibilities include:
Participate in the clinicaltrial team meetings, or, in case of a Lead CTM:
lead the clinicaltrial team meetings together with the Lead Trial PhysicianOversee risk identification and mitigations for the clinicaltrials, provide solutions and oversee implementationOversee all trial related aspects, timelines, budget and quality.
Close collaboration with the CODL on changes, issues and potential solutionsEnsure that clinicaltrials are executed according to the Clinical Development Plan (CDP), trial plans, OGSM and in compliance with argenx procedures, ICH-GCP and other applicable legislationsSupport and participate in CRO and vendor selectionLead CRO contracts negotiations together with the argenx vendor managerResponsible for leading, guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinicaltrial based upon metrics and planMember of the Country and Site Selection Commission for the specific trialProvide 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 materialsOversee and track patient recruitment and pro-actively identifies ways to prevent recruitment delaysDevelop monitoring and site oversight strategy and oversee adherence to it.
Perform site oversight visits according to planReview monitoring visit reports, protocol deviations and data listings to ensure reliable quality data are delivered and proactively identify and solve issues/concernsMonitor data qualityEnsure that the Trial Master File (TMF) is maintained and up to dateEnsure timely availability of investigational product supply on site and ensure clinical site accountability records on site are in place and maintainedEnsure 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 authoritiesEnsure supportive relationships with clinical sites and trial personnelClearly communicate on goals/expectations and motivate team members, including vendors, to work towards achieving clinicaltrial goalsPro-actively identify and solve issues in the assigned clinicaltrial and timely escalate them to CODL, Head of Trial Operations and/or Senior Management, as neededResponsible and contact person during inspections/audits for the assigned trial together with the Quality Assurance representativeIdentify efficiencies, best practices and lessons learnt.
Search for and embrace innovationThe CTM will also participate in activities other than trial-related which include but are not limited to:
Provide input to the clinical development strategy/planProvide input to procedures/SOPs/WIs and related documentsParticipate in workstreamsEnsure best practices and lessons learnt are shared across trials/indications/compoundsSkills & CompetenciesKnowledge of ICH-GCP and other applicable legislation to successfully execute the clinicaltrialExperience 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 experienceMinimum of 5 years of experience in Clinical Operations and managing CROs and vendorsBiotech experience is a plusAuto-immune and/or oncology clinicaltrial background is a plus Argenx GhentFlanders
