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Global Clinical Operations Lead
2 weeks ago
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
- 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
- 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
- M.S. (or equivalent experience) and 4+ years of relevant work experience
- B.S. (or equivalent experience) and 6+ years of relevant work experience
- Some travel required. The need for travel will vary according to study, and the life-cycle of the study.
- 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
- 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
- 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
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