Study Start Up Manager

ICON plc • Montreal, QC

2d

About The Position

Study Start Up Manager 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 As a Manager, Study Start Up at ICON, you will lead and oversee the start-up activities for clinical trials, ensuring that all processes are completed efficiently and in compliance with regulatory requirements.
What You Will Do: You will manage day-to-day site start-up and activation activities, supporting your team to deliver quality outcomes. Key responsibilities include: Managing and overseeing the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation. Leading a team of study start-up professionals, providing guidance, mentorship, and support to ensure high performance and successful project delivery. Collaborating with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation. Monitoring study start-up metrics, timelines, and budgets to ensure projects are delivered on time and within scope. Identifying potential risks and challenges in the start-up process and implementing strategies to mitigate delays or issues. Driving continuous improvement initiatives to optimize the study start-up process and enhance overall efficiency. Your Profile: You will have solid site start-up and activation experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience: Bachelor's degree in a relevant scientific discipline or healthcare-related field Extensive experience in clinical trial study start-up, with a strong understanding of global regulatory requirements and clinical operations. Proven leadership skills, with experience managing and mentoring teams in a fast-paced, deadline-driven environment. Excellent organizational and project management skills, with the ability to handle multiple studies and priorities simultaneously. Strong communication and stakeholder management skills, with the ability to collaborate effectively with sponsors and internal teams. Experience with process optimization and implementing best practices in study start-up activities. Willingness to travel as required (approximately 25%) En tant que Manager, Study Start‑Up chez ICON, vous serez responsable de la direction et de la supervision des activités de démarrage des essais cliniques, en veillant à ce que l’ensemble des processus soient réalisés de manière efficace et en conformité avec les exigences réglementaires. Vos missions Vous assurerez la gestion des activités quotidiennes de démarrage et d’activation des sites, tout en accompagnant votre équipe afin de garantir des résultats de qualité. Vos principales responsabilités incluent notamment : Gérer et superviser l’ensemble du processus de démarrage des études, de bout en bout, incluant l’identification des sites, les études de faisabilité, les soumissions réglementaires et l’activation des sites. Encadrer et diriger une équipe de professionnels du study start‑up, en apportant leadership, mentorat et soutien afin d’assurer une performance élevée et la réussite des projets. Collaborer étroitement avec les sponsors, les équipes des opérations cliniques et des affaires réglementaires afin de garantir le respect des réglementations locales et internationales ainsi que des délais de mise en place des essais cliniques. Suivre les indicateurs de performance du study start‑up, les calendriers et les budgets afin de garantir la livraison des projets dans les délais et le périmètre définis. Identifier les risques et défis potentiels liés au processus de démarrage et mettre en œuvre des stratégies de mitigation pour éviter les retards ou les problèmes. Piloter des initiatives d’amélioration continue visant à optimiser les processus de study start‑up et à renforcer l’efficacité globale. Votre profil Vous justifiez d’une solide expérience en démarrage et activation de sites, avec la capacité à gérer des priorités concurrentes tout en développant les compétences de votre équipe. Qualifications et expérience requises : Diplôme universitaire (Licence/Bachelor) dans une discipline scientifique ou un domaine lié à la santé. Expérience significative en démarrage d’essais cliniques, avec une solide connaissance des exigences réglementaires internationales et des opérations cliniques. Compétences avérées en leadership, avec une expérience confirmée dans le management et le mentorat d’équipes dans un environnement dynamique et axé sur les délais. Excellentes compétences en organisation et en gestion de projet, avec la capacité de gérer simultanément plusieurs études et priorités. Solides compétences en communication et en gestion des parties prenantes, permettant une collaboration efficace avec les sponsors et les équipes internes. Expérience en optimisation des processus et en mise en œuvre des meilleures pratiques en matière de study start‑up. Disponibilité pour des déplacements professionnels selon les besoins (environ 25 % du temps). 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised 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 ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.

Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience in clinical trial study start-up, with a strong understanding of global regulatory requirements and clinical operations.
• Proven leadership skills, with experience managing and mentoring teams in a fast-paced, deadline-driven environment.
• Excellent organizational and project management skills, with the ability to handle multiple studies and priorities simultaneously.
• Strong communication and stakeholder management skills, with the ability to collaborate effectively with sponsors and internal teams.
• Experience with process optimization and implementing best practices in study start-up activities.
• Willingness to travel as required (approximately 25%)

Responsibilities

• Managing and overseeing the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation.
• Leading a team of study start-up professionals, providing guidance, mentorship, and support to ensure high performance and successful project delivery.
• Collaborating with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation.
• Monitoring study start-up metrics, timelines, and budgets to ensure projects are delivered on time and within scope.
• Identifying potential risks and challenges in the start-up process and implementing strategies to mitigate delays or issues.
• Driving continuous improvement initiatives to optimize the study start-up process and enhance overall efficiency.

Benefits

• 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager