Description du poste
Nous recherchons un Senior Clinical Trial Specialist pour renforcer notre équipe Clinical Affairs en Suisse. Ce poste offre une opportunité de travailler dans un environnement dynamique et de contribuer à des études cliniques innovantes.TâchesCoordonner et exécuter des études cliniques sponsorisées.Assurer la gestion des sites cliniques et le suivi des activités.Maintenir la documentation des essais cliniques conforme et de qualité.CompétencesDiplôme en technologies médicales ou sciences de la vie et 5-7 ans d’expérience.Connaissance des exigences ISO 14155 et des BPC.Compétences organisationnelles et capacité à travailler de manière autonome.To strengthen our Clinical Affairs team in Switzerland, we are currently looking for aSenior Clinical Trial SpecialistJob description:The Senior Clinical Trial Specialist (Clinical Research Specialist) supports the department by coordinating and executing sponsored clinical studies, from planning activities to archiving of study documentation. Its main role is to set-up clinical investigations for Symbios medical devices products, according to EU Medical Device Regulation, ISO 14155 and other applicable regulations.Responsibilities:Support operational execution of global clinical trials following ISO 14155 and GCP requirementsEnsure clinical site management and monitoring activitiesTrack, collect and maintain audit-ready trial documentations, including regulatory submission and study specific essential documents. Maintain compliant clinical trial documentation and quality assurance (TMF)Ensure operational support of clinical study teams including the follow up on open action itemsSupport the Clinical Affairs Manager to allow timely responses to Competent Authority (in Belgium, France and Germany), physicians, other requesters for Clinical Studies topicsDevelop, implement, and maintain global Symbios database on post-marketing studies, including case report form (CRF) design, data validity check specificationsReview clinical investigation protocols and other clinical research documents for identification of data collection needs and compliance with applicable regulationsSupport data analysis and statistical activities for publication purposesWorking closely with the Clinical Affairs Manager to define project targets for external partners and ensure work is documented within the contracted project scopeDevelopment and implementation of Clinical Monitoring PlanCoordination and oversight of daily operations of the clinical monitoring team (external partner)Management of project milestones and proactively address deficienciesManagement of CRA performance (external partner)Qualifications & Required Knowledge, skills & Experience:Bachelor’s or Master’s degree in Medical Technology, Life Sciences, Clinical Affairs (or equivalent work experience in similar function)5-7 year’s experience as Trial/Study manager or strong background as Lead CRA1-2 years of experience in a medical device field (MDD/MDR requirements) specially with regulatory, quality and clinical affairsGood knowledge of the ISO 14155: ICH GCP requirementsAbility to work autonomously, exercise daily judgment based on above regulatory/clinical knowledgeResult oriented and demonstrated organizational/planning skills based on team priorityFluent in English, French and GermanGeneral Computer skills (PC, Microsoft Word/Excel/PowerPoint, Outlook/Teams)Ability to travel occasionally in Europe Lire la suite
