Description

• Assist in trial CDAs and agreements preparation with legal and other functions along with the concerned authorities at the clinical trial sites.
• Prepare templates for budget estimates and facilitates communication between internal and external partners during contract and budget phases of the CT project.
• Manage the clinical sites referencing, purchase orders, invoicing processes, regular accruals.
• Prepare the documentation package for the purpose of the submission to Independent Ethic Committee or Independent Review Board, as per respective expectations
• Report any clinical trial related relevant information to competent authorities (EUDAMED, Sunshine act...)
• Monitor and report the progress of the above activities to the CT Manager/CT Monitor
• Own the above site administrative support process
• Prepare the on-site documentation as per Good Clinical Practices (Investigator Study File - ISF)

• Handle any study paperwork or electronic documentation generated during the progress of the clinical trial
• Structure, prepare and regularly feed the electronic clinical trial master file, including all the trial documentation and main project deliverables.
• Own the above clinical trial related documentation process

• Minimum High School Diploma or Associate degree or Bachelor, required, plus 3-5 years in the industry, ideally with a clinical research background
• Good oral and written communication in French (for non-native speakers) is a nice to have
• Basic knowledge in biology or Medical devices would be a nice to have
• Skills in administrative tools (Office 365 , Teams, Outlook, …), WebApp
• Team spirit and collaborative work among peers and with department members
• Excellent sense of customer service
• good sense of adaptation, great organizational, ability to prioritize, rigor, methodical approach