Study Start Up Associate II

Study Start Up Associate I – Montréal, Canada-Remote ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. We are currently seeking a Study Start Up Associate II to join our diverse and dynamic team.As a Study Start Up Associate II at ICON, you will play a pivotal role in facilitating the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of inNovative treatments and therapies. What you will be doing Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions. Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation. Maintaining accurate and up-to-date records of regulatory submissions and approvals. Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures. Participating in study start-up meetings and providing input on regulatory requirements and timelines. Your profile Bachelor's degree in life sciences or a related field. Previous experience in clinical research or regulatory affairs is preferred. 1+ years of Study Start-Up (SSU) experience. Strong attention to detail and organizational skills. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment. Advanced French communication skills, including fluent verbal interactions and strong written proficiency for study documents and regulatory communications. Nous recherchons actuellement un(e) Associate II, Démarrage d’Étude (Study Start Up Associate II) pour rejoindre notre équipe diversifiée et dynamique.En tant qu Associate II, Démarrage d’Étude chez ICON, vous jouerez un rôle clé dans la mise en place des essais cliniques, en veillant au respect des exigences réglementaires et en contribuant à l’avancement de traitements et thérapies innovants. Vos principales responsabilités Participer à la préparation et à la soumission des documents réglementaires, tels que les demandes d’essais cliniques et les soumissions aux comités d’éthique. Plus de 1 an d’expérience en démarrage d’études cliniques (SSU). Coordonner avec les parties prenantes internes et externes pour obtenir les autorisations et approbations nécessaires au lancement des études. Maintenir des registres précis et à jour des soumissions et des approbations réglementaires. Soutenir les équipes d’étude dans l’élaboration des documents d’étude, y compris les protocoles, les formulaires de consentement éclairé et les brochures des investigateurs. Participer aux réunions de démarrage d’étude et fournir des conseils sur les exigences réglementaires et les délais. Votre profil Diplôme de licence (baccalauréat) en sciences de la vie ou dans un domaine connexe. Une expérience préalable en recherche clinique ou en affaires réglementaires est un atout. Excellente attention aux détails et solides compétences organisationnelles. Excellentes compétences en communication et en relations interpersonnelles, avec la capacité de collaborer efficacement au sein d’équipes interdisciplinaires. Capacité à travailler de manière autonome et à gérer plusieurs tâches simultanément dans un environnement dynamique. Compétences avancées en communication en français, incluant une aisance orale fluide et une excellente maîtrise écrite pour les documents d’étude et les communications réglementaires. #LI-JG1 #LI-Remote Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a current ICON Employee? Please click here to apply Apply To This Job