Study Start Up Associate II

Study Start Up Associate I – Montréal, Canada-Remote

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply