Requirements: English
Company: Excelya
Region: france, fr ,
Why Join Us? At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. Heres what makes us unique We are a young, ambitious health company representing 900 Excelyates, driven to become Europes leading mid-size CRO with the best employee experience . Our one-stop provider service model offering full-service, functional service provider, and consultingenables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patients journey. Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission. About the Job Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth. Main Responsibilities At the international level, coordinates, supervises and reports on local clinical operations (local study monitoring and management) to ensure that study activities are carried out to quality, on time and on budget. Carries out study operations tasks internally and provides supervision as delegated by the Study Team Leader (STL). Activities and responsibilities Acts as a link between field activities in the various countries involved in clinical trials, consolidating, analyzing and disseminating all relevant information to international study personnel and the study team. At international level, coordinates, supervises and reports to local/regional Clinical Operations Project Managers (COPMs) to ensure that study-related activities are carried out to the expected quality, time and budget. Actively participates in the creation of the study budget, training local teams on budget parameters, estimates and assumptions. In collaboration with 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 a clinical operations perspective, identifying significant issues in the field requiring team input, proposing solutions and also providing updates on central supplier activities as required. Ensures that international clinical operations staff are properly and timely trained on the study. Provides training on operational aspects to staff as required. Organizes and actively participates in investigator meetings and any other study-related meetings as required. Leads the execution of feasibility by country and center and analyzes and consolidates results/feedback to the study team. Following this process, 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 local COPMs, for both in-house and outsourced monitoring options. In collaboration with the Study Team Leader and study team members, defines patient recruitment strategies for the clinical trial. Responsible for creating/reviewing and updating key study documentation. Oversees subject recruitment and retention during the study and, if necessary, works proactively with COPMs to develop and propose action plans to the study team. Identifies trends in study quality issues, analyzes root causes and monitors corrective and preventive actions where necessary (protocol deviations, CAPA plans escalated by local teams, participation in data review and monitoring meetings) and, where appropriate, reports significant issues to the study team. Contributes to the selection, management and supervision of CROs/central services (central laboratory, central reading, patient services) as required. Is responsible for supervising the preparation and deployment of materials, tools and logistics for the study. During the course of the study, ensures that all documentation required for the study is assembled and properly archived in a timely manner in the study trial file. Participates in the definition and optimization of processes and the development of SOPs for clinical operations processes. Organizes and actively participates in investigator meetings and any other study-related meetings as required, also being responsible for the agenda and minutes. Manages all tasks delegated by the STL. III. Profile Pharmacist, engineer, science graduate, or equivalent. At least 5 years of experience in clinical operations. Proven project management and leadership skills. Very strong organizational and planning management sk