Study Start Up Associate I
About the role
This vacancy has now expired. Please see similar roles below...
Annonce Assistant(e) de démarrage des études (SSUA) - Montréal
ICON plc est un chef de file mondial en matière de soins de santé intelligents et de recherches cliniques. De la molécule au médicament, nous faisons progresser la recherche clinique en fournissant des services externalisés à des entreprises pharmaceutiques, biotechnologiques, de fabrication de dispositifs médicaux ainsi qu'à des organismes gouvernementaux et de santé publique.
Les patients étant au cœur de tout ce que nous faisons, nous contribuons à accélérer le développement de médicaments et de dispositifs qui sauve des vies et améliore la qualité de vie.
Nos employés constituent notre principal atout, sont l'essence de notre culture, et le moteur de notre réussite. Les employés de ICON ont pour mission de réussir et sont passionnés ce qui fait en sorte que ce que nous faisons, nous le faisons bien.
Poste - ARC principal
En tant que membre de l'équipe de mise en œuvre des études, vous jouerez un rôle essentiel pour ce qui est de vous assurer que les médecins de nos centres de recherche sont prêts à démarrer les essais de produits expérimentaux et de nouveaux produits pharmaceutiques ou biologiques pour les essais cliniques à leurs cabinets locaux.
* Coordonner, concilier et faciliter les activités liées à la finalisation des trousses des documents essentiels (CDP) et de la liste de vérification de publication du produit expérimental (SST004-SOP-F01) conformément aux directives ICH GCP et à toutes les réglementations, lois, normes éthiques, autres directives et exigences du promoteur applicables
* S'assurer que l'ensemble du processus met l'accent sur la qualité, l'efficacité et la limitation des coûts pour une région/sous-division en particulier dans le groupe CDP, sous la conduite générale du gestionnaire principal - Services centraux ou de la personne désignée.
Pour réussir dans cette fonction, vous devrez avoir :
* Un diplôme d'étude secondaire ou un équivalent local
* Un baccalauréat de préférence en sciences biologiques
* Un minimum d'un an d'expérience ou de compréhension des exigences et des activités relatives au démarrage des études cliniques
* De l'expérience quant aux activités liées aux essais cliniques et de l'expérience quant à la conformité aux directives réglementaires
* D'excellentes compétences en gestion de projet
Avantages à travailler chez ICON
Notre réussite est tributaire de la connaissance, des capacités et de la qualité de nos employés. C'est la raison pour laquelle nous sommes engagés envers le perfectionnement de nos employés dans le cadre d'une culture d'apprentissage continue. Une culture où vous êtes stimulé(e) par un travail épanouissant et où chaque expérience contribue à votre perfectionnement professionnel.
Chez ICON, nous mettons l'accent à vous offrir une rémunération globale concurrentielle qui n'inclut pas uniquement un excellent niveau salarial de base, mais aussi un vaste éventail de programmes de paye variable et de programmes de reconnaissance. De plus, nos avantages sociaux, nos politiques de soutien et nos initiatives relatives au mieux-être de catégorie supérieure sont conçus pour répondre à vos besoins et à ceux de votre famille à toutes les étapes de votre carrière, dès aujourd'hui et dans l'avenir.
ICON, ainsi que ses filiales, 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 et harcèlement. Tous les candidats qualifiés seront pris en considération de manière égale sans égard à la race, la couleur, la religion, le sexe, l'orientation sexuelle, l'identité de genre, l'origine nationale, le handicap ou le statut d'ancien combattant.
Si, en raison d'un problème médical ou d'un handicap, vous avez besoin d'un accommodement raisonnable pour une partie quelconque du processus de candidature, ou afin d'accomplir les tâches essentielles d'un poste, veuillez nous le faire savoir en remplissant le formulaire ci-dessous.
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Role:
As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.
* Coordinate, balance and facilitate activities related to the completion of Critical Document Package (CDP) and the IP release checklist (SST004-SOP-F01) in accordance with ICH GCP guidelines and all applicable regulations, laws, ethical standards, other guidelines, sponsor requirements
* Ensure that the overall process is focused on quality, efficiency and cost containment for a particular region / sub division within the CDP group, under the general mentorship of Mgr/Sr. Manager - Central Services or Designee.
What you need
* A high school diploma or local equivalent
* Bachelor's Degree preferably in Life Sciences
* Minimum of 1 years' experience or understanding of clinical study start up requirements and activities.
* Experience of Clinical Trial operations and meeting regulatory guidelines
* Proficient project management skills.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
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, 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 through the form below.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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