Clinical Trial Manager
- United States
- ICON Strategic Solutions
- Clinical Trial Management
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
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 Clinical Trial Manager.
Chez ICON, ce sont nos employé(e)s qui nous distinguent. La diversification de nos équipes fait de nous un meilleur partenaire pour nos client(e)s et nous aide à accomplir notre mission de faire progresser et d’améliorer la vie des patient(e)s.
Notre culture fondée sur l’engagement est guidée par quatre valeurs importantes qui nous rassemblent en tant qu’individus et nous distinguent en tant qu’organisation : Responsabilisation et exécution, collaboration, partenariat et intégrité. Nous visons à devenir l’organisation de recherche clinique qui offre de l’excellence à nos client(e)s et aux patient(e)s à tous les niveaux. En bref, se positionner en tant que partenaire de choix pour le développement des médicaments.
What you will be doing:
- Accountability for the performance of assigned protocols in a country in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
- To be the Country point of contact (POC) for assigned protocols and proactively drive/track execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles.
- Forecasting country resource needs and serving local business needs (sign contracts, manage budgets as delegated).
- Responsibility for quality and compliance of assigned protocols in the country and oversee CRAs and/or CTAs and training compliance.
- Performing quality control visits, reviewing Monitoring Visits Reports, and escalating performance issues and training needs to functional vendor and internal management as needed.
- Responsibility for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners.
- Overseeing country and site validations, site selection, and recruitment in assigned protocols.
- Responsibility for clinical trial education to sites and act as the country POC for programmatically outsourced trials for assigned protocols.
- Representing the client in Pharma industry issues and in seeking influence in external R&D environment.
- Collaborating internally with local Pharmacovigilance and Regulatory Affairs to align on key decisions in countries.
- Supporting local and regional strategy development consistent with long-term corporate needs in conjunction with Regional Operations.
C’est notre vision. C’est ce qui nous motive. Et nous avons besoin de personnes talentueuses avec qui la partager.
Si vous êtes aussi motivé(e) que nous, rejoignez-nous. Vous travaillerez dans un environnement dynamique et enrichissant, parmi les personnes les plus brillantes et les plus sympathiques du secteur, et vous contribuerez ainsi à améliorer notre secteur.
Rôle :
Le/la gestionnaire de l’essai clinique (GEC) est responsable de la réalisation de tous les aspects cliniques de l’étude.
Le/la GEC supervise la partie clinique du budget, élabore des plans et des outils de suivi, forme les associés de recherche clinique (ARC), pilote les activités d’inscription et de démarrage de l’étude, passe en revue les rapports de déplacement, met en œuvre des plans d’action correctifs et préventifs, assure la liaison avec le commanditaire, les fournisseurs et les équipes interfonctionnelles, identifie et atténue les risques susceptibles d’avoir un impact sur la prestation clinique, et fournit des rapports et des mesures sur toutes les activités cliniques.
Le/la GEC participera également aux réunions avec les commanditaires et les chercheur(e)s, ainsi qu’aux réunions de défense des offres.
You are:
- Proactive, collaborative, and innovative.
- Bachelor's Degree or higher required.
- A professional with Clinical Project Management or Clinical Research Management in a pharmaceutical company or global CRO with at least 3+ years of experience.
- Strong understanding of start-up activities, clinical trial planning, (site) management, and metrics.
- Strong experience in dermatology clinical trials.
- Strong communication and leadership skills.
- Ability to coordinate and lead local teams to high performance and to lead across several dimensions simultaneously.
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 maximise 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 website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.
Vous aurez besoin de :
- Un diplôme de 4 ans ou une équivalence en terme d’éducation et d’expérience
- Capacité démontrée à piloter les livrables cliniques d'une étude
- Expertise en la matière dans le domaine thérapeutique désigné
- Une expérience préalable en surveillance est souhaitée
- Capacité à voyager jusqu'à 20 % du temps
- Parler couramment la langue locale, à la fois écrite et orale
Les avantages à travailler pour ICON:
Notre réussite est tributaire de la connaissance, des capacités et de la qualité de nos employé(e)s. C'est la raison pour laquelle nous nous sommes donnés pour priorité de bâtir une culture qui récompense les hautes performances et nourrit les talents.
Nous offrons des rémunérations globales très concurrentielles. Et pour les conserver, nous les comparons régulièrement à celles de nos concurrents. Nos primes annuelles reflètent l’atteinte des objectifs de rendement — tant les nôtres que les vôtres.
Nous offrons également une vaste gamme d’avantages sociaux aux employé(e)s et à leur famille ainsi que des régimes de retraite concurrentiels — et des avantages connexes comme l’assurance vie. Vous pouvez donc économiser et planifier en toute confiance les années à venir.
Mais au-delà de la rémunération concurrentielle et d’un programme d’avantages sociaux complet, vous bénéficierez d’un environnement où vous serez encouragé(e) à satisfaire votre sentiment d’utilité et à susciter des changements durables.
ICON est un employeur inclusif, souscrivant au principe de l’égalité d’accès à l’emploi, et s’engage à offrir un milieu de travail sans discrimination ou harcèlement. Tous et toutes les candidat(e)s qualifié(e)s bénéficieront d’une considération égale pour l’emploi, sans égard pour l’ethnicité, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap ou le statut d’ancien combattant protégé.
Si, en raison d’un problème de santé ou d’un handicap, vous avez besoin d’un aménagement adéquat pour une partie du processus de candidature, ou dans le but d’exécuter les fonctions essentielles d’un poste, veuillez nous en aviser en remplissant le formulaire ci-dessous.
Êtes-vous présentement un employé d'ICON? Cliquez ici pour postuler : lien
Application process
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Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
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