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Study Start Up Associate II
Study Start Up Associate I – Montréal, Canada-Remote<br><p>ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.</p><br><p>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.</p><br><div><div>We are currently seeking a <i><b>Study Start Up Associate II </b></i>to join our diverse and dynamic team.<i><b>As a Study Start Up Associate II at ICON,</b></i> 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.</div></div><div><div><div><div><div><div><div><div><div><p></p><p><b>What you will be doing </b></p><ul><li><p>Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.</p></li></ul><ul><li><p>Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.</p></li></ul><ul><li><p>Maintaining accurate and up-to-date records of regulatory submissions and approvals.</p></li></ul><ul><li><p>Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.</p></li></ul><ul><li><p>Participating in study start-up meetings and providing input on regulatory requirements and timelines.</p></li></ul><p></p><p><b>Your profile </b></p><ul><li><p>Bachelor's degree in life sciences or a related field.</p><p>Previous experience in clinical research or regulatory affairs is preferred.</p></li><li><p>1+ years of Study Start-Up (SSU) experience.</p></li><li><p>Strong attention to detail and organizational skills.</p><p>Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.</p></li><li><p>Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.</p></li><li><p>Advanced French communication skills, including fluent verbal interactions and strong written proficiency for study documents and regulatory communications.<br> </p></li></ul><p>Nous recherchons actuellement un(e) <b>Associate II, Démarrage d’Étude (Study Start Up Associate II)</b> pour rejoindre notre équipe diversifiée et dynamique.<i><b>En tant qu Associate II, Démarrage d’Étude chez ICON, </b></i>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.</p><p></p><p><b>Vos principales responsabilités</b></p><ul><li><p>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.</p></li><li><p>Plus de 1 an d’expérience en démarrage d’études cliniques (SSU).</p></li><li><p>Coordonner avec les parties prenantes internes et externes pour obtenir les autorisations et approbations nécessaires au lancement des études.</p></li><li><p>Maintenir des registres précis et à jour des soumissions et des approbations réglementaires.</p></li><li><p>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.</p></li><li><p>Participer aux réunions de démarrage d’étude et fournir des conseils sur les exigences réglementaires et les délais.</p></li></ul><p></p><p><b>Votre profil</b></p><ul><li><p>Diplôme de licence (baccalauréat) en sciences de la vie ou dans un domaine connexe.</p></li><li><p>Une expérience préalable en recherche clinique ou en affaires réglementaires est un atout.</p></li><li><p>Excellente attention aux détails et solides compétences organisationnelles.</p></li><li><p>Excellentes compétences en communication et en relations interpersonnelles, avec la capacité de collaborer efficacement au sein d’équipes interdisciplinaires.</p></li><li><p>Capacité à travailler de manière autonome et à gérer plusieurs tâches simultanément dans un environnement dynamique.</p></li><li><p>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.</p></li></ul><p></p><p></p><p>#LI-JG1 #LI-Remote</p></div></div></div></div></div></div></div></div></div><br><p>Employment with ICON is contingent upon having the legal right to work in the country where the role is based.</p><br><p><b>Rewards & Benefits</b></p><p>ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.</p><br><p>Benefits may include:</p><ul><li>Competitive base salary and performance related incentives</li><li>Health and wellbeing programmes including medical, dental, and vision coverage where applicable</li><li>Retirement and pension plans</li><li>Life assurance and disability coverage</li><li>Employee assistance programmes and wellbeing resources</li><li>Learning and development opportunities through structured training and career pathways</li></ul><br><p>Benefits may vary depending on role and location.</p><br><p>Visit our <a href="https://careers.iconplc.com/benefits" target="_blank" rel="noopener noreferrer">careers site</a> to read more about the benefits ICON offers.</p><br><p><b>Inclusion and Accessibility</b></p><p>ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.</p><br><p>If you require reasonable accommodations during the recruitment process, please let us know or submit a request <a href="https://careers.iconplc.com/reasonable-accommodations" target="_blank" rel="noopener noreferrer"><span style="color:#0875e1"><b><u>here</u></b></span></a>.</p><p style="text-align:inherit"></p><p style="text-align:left"><span>Are you a current ICON Employee? Please click </span><a href="https://wd3.myworkday.com/icon/d/task/1422$1235.htmld" target="_blank" rel="noopener noreferrer">here</a><span> to apply</span></p>