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Regional Clinical Operations Study Lead (Clinical Project Manager) - Home-Based (US or Canada)

  1. Canada, United States
2024-109418
  1. Project Management
  2. ICON Strategic Solutions
  3. Remote

About the role

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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.

 

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.

 

Résumé du poste 

Le chef d’étude des opérations cliniques (CEOC) est responsable de la gestion indépendante de plusieurs essais cliniques de complexité modérée, ou de la gestion d’un éventail plus large d’activités concernant de grandes études multicentriques. Le CEOC est censé régler les problèmes liés au centre et aux fournisseurs, grâce à une assistance adaptée. 


  • 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

 

Responsabilités 

  • Élaborer et superviser le(s) plan(s) opérationnel(s) de l’étude 
  • Coordonner les activités de développement clinique internes et externes de tous les membres de l’équipe participant à l’élaboration et à la réalisation des essais cliniques assignés 
  • Contribuer à l’élaboration et à la stratégie des protocoles ainsi qu’à la résolution des problèmes médicaux 
  • Participer à l’examen des données de l’étude et aider à la rédaction d’un compte-rendu du patient, ainsi qu’à d’autres activités d’examen des données, selon les besoins. 
  • Contribuer de manière significative à la documentation pertinente de l’étude notamment les protocoles cliniques, le plan d’analyse statistique et les rapports d’étude clinique 
  • Identifier de manière proactive les risques liés au projet et les maîtriser avec une supervision adéquate 
  • Participer à la sélection des chercheurs et des fournisseurs 
  • Pouvoir servir de mentor à des employés plus jeunes du service des opérations cliniques ou participer à l’intégration des nouveaux employés 
  • Représenter les opérations cliniques dans les démarches interfonctionnelles, selon les directives de la direction, et pouvoir agir au nom de l’équipe 
  • Mener à bien toute autre tâche confiée 

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.

 

Compétences 

Compétences techniques et de communication : 

  • Résultats probants en matière de gestion d’études, démontrant une compétence claire en matière de gestion de projets cliniques. Excellentes compétences en matière de gestion des fournisseurs 
  • Large compréhension des opérations, y compris celles des fonctions de développement connexes 
  • Faire preuve d’une compréhension élaborée du protocole clinique, des populations visées par l’étude ainsi que du développement global du médicament 
  • Démontrer une capacité à communiquer efficacement avec le personnel médical de priorité du ou des centres clinique(s) 
  • Démontrer sa capacité à diriger des équipes pluridisciplinaires 
  • Posséder d’excellentes compétences en communication écrite et orale 

 

Formation et expérience souhaitées : 

  • M.S. (ou expérience équivalente) et 4 années ou plus d’expérience professionnelle pertinente 
  • B.S. (ou expérience équivalente) et 6 années ou plus d’expérience professionnelle pertinente 

 

 

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

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.

 

**Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.**

 

Les avantages de travailler pour ICON : 
 
Notre succès dépend des connaissances, des capacités et de la qualité de notre personnel. C’est pourquoi nous nous engageons à former nos employé(e)s dans une culture d’apprentissage continu — une culture où nous vous mettons au défi de faire du travail intéressant et où chaque expérience contribue à votre perfectionnement professionnel. 
 
Chez ICON, notre objectif est de vous offrir une rémunération globale complète et concurrentielle qui comprend non seulement un excellent salaire de base, mais aussi un large éventail de programmes de rémunération variable et de reconnaissance. De plus, nous offrons des avantages sociaux, des mesures de soutien et des initiatives de bien-être de première qualité, afin de vous soutenir, vous et votre famille, à toutes les étapes de votre carrière, maintenant et à l’avenir. 
 
ICON, y compris ses filiales, est un employeur inclusif qui offre des chances égales et s’engage à offrir un cadre de travail exempt de discrimination et de harcèlement. Tous et toutes les candidat(e)s qualifié(e)s bénéficieront d’une considération égale pour l’emploi, sans distinction par rapport 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 protégé. 
 
Si, en raison d’un problème de santé ou d’un handicap, vous avez besoin d’aménagements adaptés et raisonnables pour toute partie du processus de candidature, ou pour exécuter les fonctions essentielles d’un poste, veuillez nous en informer au moyen du formulaire ci-dessous. 

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