Study Start Up Associate I - Montreal, 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
Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.
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, Demarrage d'Etude (Study Start Up Associate II) pour rejoindre notre equipe diversifiee et dynamique.En tant qu Associate II, Demarrage d'Etude chez ICON, vous jouerez un role cle dans la mise en place des essais cliniques, en veillant au respect des exigences reglementaires et en contribuant a l'avancement de traitements et therapies innovants.
Vos principales responsabilites
Participer a la preparation et a la soumission des documents reglementaires, tels que les demandes d'essais cliniques et les soumissions aux comites d'ethique.
Plus de 1 an d'experience en demarrage d'etudes cliniques (SSU).
Coordonner avec les parties prenantes internes et externes pour obtenir les autorisations et approbations necessaires au lancement des etudes.
Maintenir des registres precis et a jour des soumissions et des approbations reglementaires.
Soutenir les equipes d'etude dans l'elaboration des documents d'etude, y compris les protocoles, les formulaires de consentement eclaire et les brochures des investigateurs.
Participer aux reunions de demarrage d'etude et fournir des conseils sur les exigences reglementaires et les delais.
Votre profil
Diplome de licence (baccalaureat) en sciences de la vie ou dans un domaine connexe.
Une experience prealable en recherche clinique ou en affaires reglementaires est un atout.
Excellente attention aux details et solides competences organisationnelles.
Excellentes competences en communication et en relations interpersonnelles, avec la capacite de collaborer efficacement au sein d'equipes interdisciplinaires.
Capacite a travailler de maniere autonome et a gerer plusieurs taches simultanement dans un environnement dynamique.
Competences avancees en communication en francais, incluant une aisance orale fluide et une excellente maitrise ecrite pour les documents d'etude et les communications reglementaires.
#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 requesthere.
Are you a current ICON Employee? Please click here to apply