Management of national and international clinical and observational trials (Phase I to III) in oncology, ophtalmology, diabetes and gastro-enterology fields
Internal team and on-field CRAs coordination and training
Follow-up of monitoring activities (reports, protocol deviations, AE/SAE, issues/actions) and of patient recruitment
Logistical management of the study (IMP, site and patient documents, materials...)
Study documents writing/review with the sponsor (protocol, informed consent form, electronic and paper CRF, investigator files, specific study SOPs and according to local reglementation)
TMF management and audits preparation (CRO and sites)
Study budget management
Management of financial agreements and payments (fees and extracosts, Transparency declaration)
Management of communication with sponsor (TC/regular face to face meeting) and sites (Flashnews, Newsletters)
Preparation of "Data Review Meeting", "Steering Committee Meeting" (Phase I in USA), medico-scientific review of patient data, queries management
Management of regulatory submissions/notifications
Management of service providers (central laboratories, CROs, printers)
On-field activities : prestudy, initiation, monitoring, close-out and field-based CRAs quality control visits
