Madrid, Community of Madrid, Spain
Before joining the Clinical Research Industry, I spent one year in Cambridge (UK) doing a postgraduate studies and then I conducted research in Portugal through a grant provided by Museu Nacional de História Natural e da Ciência (Lisbon, Portugal). A hard-working, self-motivated and highly conscientious Clinical Research Professional with more than 10 years’ experience working with Spanish and Portuguese hospitals in the Pharmaceutical industry. Since 2022 leading all clinical trials activities. I am very passionate about my work; my capacity to work on several studies required performing different activities, all of them with success. I work both independently, but also within a good team environment and I have proactively focused in solving problems and prioritizing tasks working together with the other team members in order to ensure the project timelines. I am very interested to take on new challenges, the dedication and motivation increases with the level of the difficult to research a goal.
Lead role since March 2022 in charge of Europe team. Leading all clinical trials activities from start up of the project to close out activities. Also involved in training activities, audits and inspections, financial resources, budget and client expectations.
• Support and train Initiation Clinical Site Manager colleagues in relevant systems and troubleshooting - this includes CTMS, EDC, Site Start-Up Tool, Document Management, Safety Reporting System, etc • Regularly perform a holistic review of end-user reported questions and incidents to look for patterns and systematic issues that can be proactively addressed before becoming a serious issue for that role. • Serve on implementation teams for new system versions and process improvement initiatives, providing user view point for system configuration, feasibility assessments, brainstorming and other activities required by the implementation team. • Execute UATs for systems that are used by the SU’s role. • Deliver system presentations in response to client or internal requests
• Clinical Site’s main point of contact for assigned sites, accountable for quality and delivery of sites during the pre-SIV / start-up phase. Manages country specific feasibility, site pre-qualification and qualification activities • Generate visit/contact reports in accordance with monitoring plans. • Configure, distribute, collect, review, and approve essential regulatory documents (SRP) Customize, review, and negotiate as required, country/site specific Informed Consent Forms (ICF), translations (in accordance with country/regulatory/client requirements), and any amendments. • Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy. • IRB/IEC and MoH / RA submission/approval and site activation and patient recruitment & retention. • Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner, as indicated per project requirements.
Support the students and work very close with them during the lecturers in the Animal and Plans Diversity subjects
Providing administrative support to the clinical operations team. General responsibilities include: assistance with CRFs, queries, newsletters and SAEs delivery, central co-ordination and archiving of clinical study documents, attendance at teleconference, closure visits and submissions to EC.