Job Description

Overview

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.

Position Summary

The Clinical Operations Study Lead is responsible for independently managing multiple clinical trials of moderate complexity or managing a broader range of activities on large multi-center studies. The COSL is expected to address site and vendor-related issues, with assistance as needed.

ICON plc est un chef de file mondial en mati\xc3\xa8re de soins de sant\xc3\xa9 intelligents et de recherches cliniques. De la mol\xc3\xa9cule au m\xc3\xa9dicament, nous faisons progresser la recherche clinique en offrant des services externalis\xc3\xa9s aux entreprises pharmaceutiques, biotechnologiques et d\xe2\x80\x99\xc3\xa9quipement m\xc3\xa9dical, ainsi qu\xe2\x80\x99aux organismes gouvernementaux et de sant\xc3\xa9 publique. En pla\xc3\xa7ant nos patients au c\xc5\x93ur de toutes nos activit\xc3\xa9s, nous contribuons \xc3\xa0 acc\xc3\xa9l\xc3\xa9rer le d\xc3\xa9veloppement de m\xc3\xa9dicaments et de dispositifs, qui sauvent des vies et am\xc3\xa9liorent la qualit\xc3\xa9 de vie. Nos employ\xc3\xa9(e)s sont le fer de lance de notre culture et constituent la force motrice de notre succ\xc3\xa8s. Les employ\xc3\xa9(e)s d\xe2\x80\x99ICON ont pour mission de r\xc3\xa9ussir et sont anim\xc3\xa9(e)s d\xe2\x80\x99une passion qui garantit que ce que nous faisons, nous le faisons bien.

R\xc3\xa9sum\xc3\xa9 du poste

Le chef d\xe2\x80\x99\xc3\xa9tude des op\xc3\xa9rations cliniques (CEOC) est responsable de la gestion ind\xc3\xa9pendante de plusieurs essais cliniques de complexit\xc3\xa9 mod\xc3\xa9r\xc3\xa9e, ou de la gestion d\xe2\x80\x99un \xc3\xa9ventail plus large d\xe2\x80\x99activit\xc3\xa9s concernant de grandes \xc3\xa9tudes multicentriques. Le CEOC est cens\xc3\xa9 r\xc3\xa9gler les probl\xc3\xa8mes li\xc3\xa9s au centre et aux fournisseurs, gr\xc3\xa2ce \xc3\xa0 une assistance adapt\xc3\xa9e.

Responsibilities

• Develops and oversees study operational plan(s)
• Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
• Assists with protocol design and strategy and medical issue resolution,
• Participates in study data review and assists with patient narrative writing and other data review activities as assigned.
• Contributes significantly to relevant study documentation including clinical protocols, statistical analysis plan, and clinical study reports
• Proactively identifies project risks and resolves with some supervision
• Participates in the selection of Investigators and vendors
• May mentor more junior Clinical Operations Staff or participate in the on boarding of new personnel
• Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team
• Performs other duties as assigned

Responsabilit\xc3\xa9s

• \xc3\x89laborer et superviser le(s) plan(s) op\xc3\xa9rationnel(s) de l\xe2\x80\x99\xc3\xa9tude
• Coordonner les activit\xc3\xa9s de d\xc3\xa9veloppement clinique internes et externes de tous les membres de l\xe2\x80\x99\xc3\xa9quipe participant \xc3\xa0 l\xe2\x80\x99\xc3\xa9laboration et \xc3\xa0 la r\xc3\xa9alisation des essais cliniques assign\xc3\xa9s
• Contribuer \xc3\xa0 l\xe2\x80\x99\xc3\xa9laboration et \xc3\xa0 la strat\xc3\xa9gie des protocoles ainsi qu\xe2\x80\x99\xc3\xa0 la r\xc3\xa9solution des probl\xc3\xa8mes m\xc3\xa9dicaux
• Participer \xc3\xa0 l\xe2\x80\x99examen des donn\xc3\xa9es de l\xe2\x80\x99\xc3\xa9tude et aider \xc3\xa0 la r\xc3\xa9daction d\xe2\x80\x99un compte-rendu du patient, ainsi qu\xe2\x80\x99\xc3\xa0 d\xe2\x80\x99autres activit\xc3\xa9s d\xe2\x80\x99examen des donn\xc3\xa9es, selon les besoins.
• Contribuer de mani\xc3\xa8re significative \xc3\xa0 la documentation pertinente de l\xe2\x80\x99\xc3\xa9tude notamment les protocoles cliniques, le plan d\xe2\x80\x99analyse statistique et les rapports d\xe2\x80\x99\xc3\xa9tude clinique
• Identifier de mani\xc3\xa8re proactive les risques li\xc3\xa9s au projet et les ma\xc3\xaetriser avec une supervision ad\xc3\xa9quate
• Participer \xc3\xa0 la s\xc3\xa9lection des chercheurs et des fournisseurs
• Pouvoir servir de mentor \xc3\xa0 des employ\xc3\xa9s plus jeunes du service des op\xc3\xa9rations cliniques ou participer \xc3\xa0 l\xe2\x80\x99int\xc3\xa9gration des nouveaux employ\xc3\xa9s
• Repr\xc3\xa9senter les op\xc3\xa9rations cliniques dans les d\xc3\xa9marches interfonctionnelles, selon les directives de la direction, et pouvoir agir au nom de l\xe2\x80\x99\xc3\xa9quipe
• Mener \xc3\xa0 bien toute autre t\xc3\xa2che confi\xc3\xa9e

Qualifications

Technical and Communicative Skills:

• Strong study management track record showing clear proficiency in clinical project management skills. Solid vendor management skills
• Broad understanding of operations including those in related development functions
• Demonstrates detailed understanding of clinical protocol, intended study populations as well as solid overall drug development
• Demonstrates ability to effectively interface with key medical personnel at clinical site(s)
• Demonstrates ability to lead multi-disciplinary teams
• Possesses excellent written and oral communications skills

Preferred Education and Experience:

• M.S. (or equivalent experience) and 4+ years of relevant work experience
• B.S. (or equivalent experience) and 6+ years of relevant work experience

Travel:

• Some travel required. The need for travel will vary according to study, and the life-cycle of the study.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That\xe2\x80\x99s why we are committed to developing our employees in a continuous learning culture \xe2\x80\x93 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.

Comp\xc3\xa9tences

Comp\xc3\xa9tences techniques et de communication :

• R\xc3\xa9sultats probants en mati\xc3\xa8re de gestion d\xe2\x80\x99\xc3\xa9tudes, d\xc3\xa9montrant une comp\xc3\xa9tence claire en mati\xc3\xa8re de gestion de projets cliniques. Excellentes comp\xc3\xa9tences en mati\xc3\xa8re de gestion des fournisseurs
• Large compr\xc3\xa9hension des op\xc3\xa9rations, y compris celles des fonctions de d\xc3\xa9veloppement connexes
• Faire preuve d\xe2\x80\x99une compr\xc3\xa9hension \xc3\xa9labor\xc3\xa9e du protocole clinique, des populations vis\xc3\xa9es par l\xe2\x80\x99\xc3\xa9tude ainsi que du d\xc3\xa9veloppement global du m\xc3\xa9dicament
• D\xc3\xa9montrer une capacit\xc3\xa9 \xc3\xa0 communiquer efficacement avec le personnel m\xc3\xa9dical de priorit\xc3\xa9 du ou des centres clinique(s)
• D\xc3\xa9montrer sa capacit\xc3\xa9 \xc3\xa0 diriger des \xc3\xa9quipes pluridisciplinaires
• Poss\xc3\xa9der d\xe2\x80\x99excellentes comp\xc3\xa9tences en communication \xc3\xa9crite et orale

Formation et exp\xc3\xa9rience souhait\xc3\xa9es :

• M.S. (ou exp\xc3\xa9rience \xc3\xa9quivalente) et 4 ann\xc3\xa9es ou plus d\xe2\x80\x99exp\xc3\xa9rience professionnelle pertinente
• B.S. (ou exp\xc3\xa9rience \xc3\xa9quivalente) et 6 ann\xc3\xa9es ou plus d\xe2\x80\x99exp\xc3\xa9rience professionnelle pertinente

Les avantages de travailler pour ICON :

Notre succ\xc3\xa8s d\xc3\xa9pend des connaissances, des capacit\xc3\xa9s et de la qualit\xc3\xa9 de notre personnel. C\xe2\x80\x99est pourquoi nous nous engageons \xc3\xa0 former nos employ\xc3\xa9(e)s dans une culture d\xe2\x80\x99apprentissage continu \xe2\x80\x94 une culture o\xc3\xb9 nous vous mettons au d\xc3\xa9fi de faire du travail int\xc3\xa9ressant et o\xc3\xb9 chaque exp\xc3\xa9rience contribue \xc3\xa0 votre perfectionnement professionnel.

Chez ICON, notre objectif est de vous offrir une r\xc3\xa9mun\xc3\xa9ration globale compl\xc3\xa8te et concurrentielle qui comprend non seulement un excellent salaire de base, mais aussi un large \xc3\xa9ventail de programmes de r\xc3\xa9mun\xc3\xa9ration variable et de reconnaissance. De plus, nous offrons des avantages sociaux, des mesures de soutien et des initiatives de bien-\xc3\xaatre de premi\xc3\xa8re qualit\xc3\xa9, afin de vous soutenir, vous et votre famille, \xc3\xa0 toutes les \xc3\xa9tapes de votre carri\xc3\xa8re, maintenant et \xc3\xa0 l\xe2\x80\x99avenir.

ICON, y compris ses filiales, est un employeur inclusif qui offre des chances \xc3\xa9gales et s\xe2\x80\x99engage \xc3\xa0 offrir un cadre de travail exempt de discrimination et de harc\xc3\xa8lement. Tous et toutes les candidat(e)s qualifi\xc3\xa9(e)s b\xc3\xa9n\xc3\xa9ficieront d\xe2\x80\x99une consid\xc3\xa9ration \xc3\xa9gale pour l\xe2\x80\x99emploi, sans distinction par rapport \xc3\xa0 la race, la couleur, la religion, le sexe, l\xe2\x80\x99orientation sexuelle, l\xe2\x80\x99identit\xc3\xa9 de genre, l\xe2\x80\x99origine nationale, le handicap ou le statut d\xe2\x80\x99ancien combattant prot\xc3\xa9g\xc3\xa9.

Si, en raison d\xe2\x80\x99un probl\xc3\xa8me de sant\xc3\xa9 ou d\xe2\x80\x99un handicap, vous avez besoin d\xe2\x80\x99am\xc3\xa9nagements adapt\xc3\xa9s et raisonnables pour toute partie du processus de candidature, ou pour ex\xc3\xa9cuter les fonctions essentielles d\xe2\x80\x99un poste, veuillez nous en informer au moyen du formulaire ci-dessous.

ICON