International Clinical Operations Lead – France

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

What we offer:

• Acts as a liaison between field activities in the different countries participating in clinical trials, consolidating, analyzing and disseminating any relevant information to international study personnel and the Study Team.
• At the international level, coordinates, oversees and reports on the local/regional Clinical Operations Project Managers (COPMs) to ensure that study-related activities are conducted according to expected quality, timelines and budget.
• Actively participates in the study budget creation, train local teams on the budget drivers, estimations and assumptions. In collaboration with the COPMs, develops, manages and reports on the local study budget (external and internal costs)
• Actively participates in Study Team meetings, providing up-to-date and concise information on study progress from the clinical operations perspective, identifying important field operations issues that require input from the Team, proposing solutions and providing also updates on central vendors activities as relevant
• Ensures that the international Clinical Operations personnel are adequately trained on the study and in a timely manner. Provides training in operational aspects to personnel as required. Organizes and participates actively to the Investigator meetings and any other study-related meetings as needed.
• Leads the execution of the country and center feasibility and analyses and consolidates the results/feedback to the Study Team. As result of this process, he/she proposes different scenarios to the study team
• In collaboration with the Study Team Leader, identifies an appropriate monitoring strategy, then develops the Monitoring Plan with input from the local COPMs, both for in-house and outsourced monitoring choices.
• In collaboration with Study team leader and study team actors, she /he defines the patient in strategies for the clinical trial.
• Responsible of the creation/ review and update of key study documentation
• Oversees subject recruitment and retention during the study and, when necessary, pro-actively works with COPMs to develop and propose action plans to the Study Team.
• Detects study quality issues trends, root cause analysis & follow-up corrective and preventive actions as necessary (protocol deviations, CAPA plans escalated by local teams, participation in Data Review and Surveillance meetings) and when relevant, reports important issues to the Study Team.
• -Contributes to the selection, management and oversight as applicable  of Full service CROs / central vendors (central lab, central reading, Patient services…)
• Be responsible for  the oversight of the preparation and deployment of materials, tools and logistics for the study.
• During the course of the study, ensures that all necessary study documentation is gathered and correctly filed  on a timely basis  in the study Trial Master File.
• Participates in process definition and optimisation and SOP development efforts with regard to Clinical Operations processes.
• Organizes and participates actively to the Investigator meetings and any other study-related meetings as needed, being also responsible for the agenda and the minute