Eva Font Email & Phone Number

Madrid, Comunidad De Madrid, España

As Director of the Start-Up and Regulatory Unit, I am responsible for the Regulatory advice, and correct implementation of regulatory procedures in company studies as well as in BID proccess. As the same time, I oversee the Regulatory Unit staff, taking care of the training and mentoring of the team, that includes Regulatory Managers, Leads and Associates. Acting as contact person for Clients for regulatory advice and strategic support. Assisting Clinical Operations and PM team in regulatory aspects of the studies.

Madrid, Comunidad De Madrid, España

Acting as Country Start-up Manager, responsible for supervision of assigned direct reports within Start-up Operations Staff in Spain and Portugal

Madrid Y Alrededores, España

Madrid Y Alrededores, España

Madrid Y Alrededores, España

Responsibilities include coordinating the Start-up functional team members and their activities across a defined region or within specific functions to ensure that the Global Research Operations deliverables (timeline, quality, productivity) are met.I work on global, multicenter studies with responsibility for the coordination of all start-up activities including site qualification, regulatory documents collection, EC submission and adaptation/translation of local ICF.

Madrid, Comunidad De Madrid, España

As local coordinator of the SSU study team, I conduct and facilitate specific start-up activities such as feasibility and site identification, collect and review SRP documents, ICF customization and approval, check patient insurance certificate, EC submissions and Hospital and Investigator agreement negotiation as well as provide status updates as required.I also act as mentor for less experienced CTS, and assist SSU Key Contact in keeping databases up to date, in the development and implementation of the SSU related processes and tools, and perform quality checks, while maintaining a working knowledge of global and local regulations.

As local medical department coordinator I performed the line management of MRA and MR Admin; organization and co-ordination of Ethics Committee submissions and safety communications for all Madrid office studies and customization of ICF for clinical trials.

Local team coordination, Study Start-up: Feasibilities, Investigator Selection, ECs and HA submission, Contracts and study budget negotiation.Site Management: Contact to Study staff, Initiation, Monitoring and Close-up visits, Data Management, including e-CRF, SAEs notificationAttendance and Make Presentations in Monitors Meetings; Manage Client Audits, Mentoring new staff, Contact to Client Local Affiliates.

Post-Graduado, Especialista En Ensayos Clínicos

Ldo., Farmacia