Global Clinical Operations Lead (COSL) - Home-Based (US or Canada)
- Canada, United States
- Project Management
- ICON Strategic Solutions
- Remote
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.
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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Read more
Day in the life
Teaser label
Career ProgressionContent type
BlogsPublish date
05/10/2024
Summary
Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv
Teaser label
Career ProgressionContent type
BlogsPublish date
07/20/2023
Summary
Unlocking your Potential: The Benefits of ICON’s EPIC Internship Program Internship programs have become a vital stepping stone for students and young professionals seeking to gain practic
Teaser label
Career ProgressionContent type
BlogsPublish date
05/30/2023
Summary
Clinical research is the backbone of the life sciences industry. In fact, the established processes used to accurately trial and research medical, surgical and behavioural intervention are ess
Similar jobs at ICON
Salary
Location
Mexico, Mexico City
Department
Full Service - Development & Commercialisation Solutions
Location
Mexico City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Project Management
Project Management
Job Type
Permanent
Description
JR124876Laboratory Proj. CoordinatorSite: Mexico, Mexico CityOffice with Flex (3 days at office, and 2 days at home)At ICON, it’s our people that set us apart. Our diverse teams enable us to become a
Reference
JR124876
Expiry date
01/01/0001
Author
Fernanda BezerraAuthor
Fernanda BezerraSalary
Location
United States, Canada
Department
Project Management Roles
Location
Canada
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Project Management
Job Type
Permanent
Description
As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-113616
Expiry date
01/01/0001
Author
Melissa BennerAuthor
Melissa BennerSalary
Location
United States
Department
Project Management Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Project Management
Job Type
Permanent
Description
As an Outcomes Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114481
Expiry date
01/01/0001
Author
Brandon PupekAuthor
Brandon PupekSalary
Location
United States
Department
Project Management Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Project Management
Job Type
Permanent
Description
The Clinical Trial Manager (CTM) plays a vital role in managing the operational aspects of clinical studies, ensuring global accountability from the Final Protocol Concept Sheet to the Clinical Study
Reference
2024-114085
Expiry date
01/01/0001
Salary
Location
US, Portland, OR
Department
Full Service - Development & Commercialisation Solutions
Location
Portland
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Project Management
Project Management
Job Type
Permanent
Description
Senior Project Manager, Laboratory- Location: Portland OR- Hybrid • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on str
Reference
JR124049
Expiry date
01/01/0001
Author
Frank LampartAuthor
Frank LampartSalary
Location
United States
Department
Project Management Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Project Management
Job Type
Permanent
Description
As a CAPA Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-113727
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica Hawkins