Clinical Study Support Officer (H/F)

Support the Clinical Studies Support Manager (CSSM) in managing and coordinating training activities, providing functional support and ensuring the quality control of data for monitoring IT tools, and evaluating Clinical Operations KPIs. Assist the ICTR Director in resource tracking and the validation of FTE invoices Activities & Responsibilities 1. Training coordination and Management • Planning, preparation and monitoring of the initial training for new employees with the line managers • Maintaining and updating training materials, user guides, and documentation • Organising and supporting the management of all activities related to training, including tracking and record-keeping • Track training performance by creating and evaluating KPIs and metrics within the HUB hierarchy • Providing training, if applicable • Acting as Training Correspondent back-up 2. Systems and Digital Tools Support & Data Quality • Acting as HUB-level key user for clinical systems and tools (TMMCS, eTMF, SharePoint-based trackers, etc) • Supporting the CSSMs in the follow-up of study, country and site-level study execution, including milestone follow-up. • Performing regular quality control (QC) of operational data in systems (e.g., TMMCS, SELECT, trackers). Identifying inconsistencies, delays, or risks and proactively follow up with relevant stakeholders (study teams at local or central level) • Supporting:  User access management in collaboration with the GCOS assistants  Issue resolution and troubleshooting  System adoption and best practices • Supporting the preparation of GCOS level operational overviews and tracking tools. 3. KPIs and Performance • Supporting the preparation and consolidation of KPIs and performance dashboards • Highlighting data gaps and follow up on corrective actions with CSSMs and/or stakeholders. 4. Resource Allocation & FTE Invoice Management • Assisting the ICTR Director in resource allocation tracking and ensuring the accuracy of FTE invoice validation to support budget monitoring.

Context & Environment: The candidate will operate within a dynamic, multicultural environment, reporting functionally to the CSSM and interacting daily with Clinical Operations teams across the international network to ensure global alignment and compliance. Education: Bachelor’s or Master’s degree in Data Analysis, Business Administration, Health Industries Management, or a Scientific field with a strong analytical tilt. Technical Expertise: good Excel skills are critical (must be comfortable with Macros, Pivot Tables, and handling large datasets). Knowledge & Experience: - foundational knowledge of GCP (Good Clinical Practice) and the clinical trial process is highly preferred. - familiarity with clinical database environments (CTMS/TMMCS) is a significant plus. Competencies: high level of precision (data integrity is paramount), strong organizational skills, and an analytical mindset to interpret KPIs. Languages: fluency in English (written and spoken) is mandatory for international coordination. Basic Italian is an asset to facilitate team integration.

Les études de conception, notamment au niveau des études Pre-cliniques et cliniques, l'organisation, la coordination, le développement et la planification de toutes études dans la recherche médicale et pharmaceutique, la recherche et l'exploitation de nouvelles orientations