Responsable des opérations cliniques, Manager, Clinical Operations

IQVIA•Kirkland, QC

48d

About The Position

Aperçu du poste Gérer une équipe de personnel clinique travaillant à l’appui des études cliniques pour garantir que les projets disposent des ressources appropriées et que les employés sont formés et atteignent les objectifs du projet. Fonctions essentielles • Gérer le personnel conformément aux politiques de l’organisation et aux règlements applicables. Les responsabilités comprennent la planification, l’attribution et la direction du travail, l’évaluation des performances et l’orientation du développement professionnel, la récompense et la discipline des employés, ainsi que le traitement des questions de relations avec les employés et la résolution des problèmes. • Participer à la sélection pour l’embauche de nouveaux employés en effectuant l’évaluation des candidats et en participant au processus d’entrevue. S’assurer que les nouveaux employés sont correctement intégrés et formés. • S’assurer que le personnel dispose du matériel, de l’accès aux systèmes et de la formation appropriés pour s’acquitter de ses responsabilités professionnelles. Assurer la supervision de l’exécution du plan de formation, de l’examen des procédures opérationnelles standard et des expériences de formation, le cas échéant. • Participer à l’allocation des ressources aux projets de recherche clinique en affectant du personnel aux études cliniques en fonction de son expérience et de sa formation. • Gérer la qualité du travail clinique du personnel assigné en examinant et en évaluant régulièrement le produit du travail. • Identifier les risques et les problèmes de qualité et créer des plans d’action correctifs appropriés pour prévenir ou corriger les déficiences dans la performance du personnel. • Veiller à ce que le personnel respecte les paramètres définis en matière de charge de travail et de qualité en procédant à un examen régulier et en rendant compte des résultats, comme indiqué par la direction des opérations cliniques. • Collaborer, le cas échéant, avec d’autres équipes cliniques et d’autres responsables fonctionnels afin de gérer les défis liés aux projets et de fournir un service à la clientèle exemplaire. • Participer aux initiatives d’amélioration de la qualité ou des processus au niveau de l’entreprise ou de l’organisation. Job Overview Manage a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and meeting project objectives. Essential Functions • Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development, rewarding and disciplining employees, and addressing employee relations issues and resolving problems. • Participate in the selection for hiring new employees by conducting candidate review and participating in the interviewing process. Ensure that new employees are properly onboarded and trained. • Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and training experiences, as applicable. • Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training. • Manage the quality of assigned staff's clinical work through regular review and evaluation of work product. • Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff. • Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management. • May collaborate with other clinical teams and other functional leadership to manage project related challenges and to achieve exemplary customer service. • Participates in corporate or organizational departmental quality or process improvement initiatives.

Requirements

Bachelor's Degree Degree in scientific discipline or health care preferred.
Prior clinical trial experience including experience in a management/leadership capacity or equivalent combination of education, training and experience.
In-depth knowledge of applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
Good leadership skills.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
Written and verbal communication skills including good command of English.
Excellent organizational and problem solving skills.
Effective time management skills and ability to manage competing priorities.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Responsibilities

Manage staff in accordance with organization’s policies and applicable regulations.
Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development, rewarding and disciplining employees, and addressing employee relations issues and resolving problems.
Participate in the selection for hiring new employees by conducting candidate review and participating in the interviewing process.
Ensure that new employees are properly onboarded and trained.
Ensure that staff has the proper materials, systems access and training to complete job responsibilities.
Provide oversight for the execution of the training plan, SOP review and training experiences, as applicable.
Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training.
Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
May collaborate with other clinical teams and other functional leadership to manage project related challenges and to achieve exemplary customer service.
Participates in corporate or organizational departmental quality or process improvement initiatives.