Clinical Team Manager
Since June 2015
As a clinical team manager I'm the person in charge of providing the clients with all the deliverables requested but keeping an eye on time and costs as well as in the quality provided.
Senior Clinical Research Associate II /Lead CRA
April 2014 --- May 2015
Promoted to Senior CRA II and participating as Lead CRA tasks from June 2013 on HIV studies. Apart from that, I've performed Clinical Team Manager back-up for two HIV studies during former CTMs' holidays period. During my CTM back-up experience I participated in some client calls providing detailed data regarding recruitment status for EMEA sites and start-up process (tools implementation as EDC access, central lab access...) Apart from that, as LCRA I've escalated to CTMs as well as to the Sponsor directly any risk during the Interim Analysis for any procedure or data that could not achive the client milestones (subjects Out Of Window for the LPLV date, data non verified at the time of the DB lock...) As CTM back-up I was involved in action/prevention/mitigation plans cascade for the study providing client deliverables on time with the best quality within the cost limits. Developing CRA tasks in ophtalmology studies since December 2014 Apart during 4 months I have been developing Clinical Manager Facilitator tasks, i.e: - I have reviewed Spanish Annual Reports to be submitted to the AEMPS and Ethics Committees pointed out any missing information for different studies/areas. - Issues solving coordinator for Spanish office, decreasing the figures of studies with open issues/deviations older than 45 days. - I have leadered some workshops within the Spanish office regarding "embracing the change" topic. - Instructor for the new Research Assistants preparing them for Clinical Operations foundation program.
Senior Clinical Research Associate (CRA)
September 2011 --- April 2014
I perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. I conduct site visits to determine protocol and regulatory compliance, and prepare required documentation. I develop collaborative relationships with investigative sites and client company personnel. I've performed pre-study visits, site initiation visits, co-monitoring visits and site interim monitoring visits, meeting the client requisitions and being congratulated by the sponsor due to the great performance in the study initiation at the country for one study. I've worked in: - Feasibilities - Phase III studies regarding HIV - Phase IV studies regarding HIV Award of excellence 2012 received for making Spain the Country with the First Patient included in the EMEA for the HIV study. Main Spanish contact in the organization of the 1st international sports meeting for PPD managing the personnel involved for the Spanish team. Mentoring program for Junior Clinical Research Associates. Involved in the assessment visits program for PPD advising other CRAs on their performance during their different monitoring visits. Lead CRA tasks since June 2013 supporting some countries as The United Kingdom, Italy, Switzerland, Austria, Belgium, Sweden, the Netherlands and Spain. Some of these tasks are: - Supporting teams to set up the study in their respective countries - Managing the CRAs in order to achive the milestones indicated by the client (Data cut-offs, sites' start up, sites' communications, sites' principal contact in case of necessity) - To review visit reports in order to guarantee that quality requirements indicated by the client as well as PPD are met - Providing help as leadCRA to the team by managing some vendors and centralizing the requested data by the client in order to provide the results in the fastest way possible.
April 2012 --- January 2014
Entrepeneur as well as independent distributor in this enterprise related to healthcare. Great brand products based in the Açai berry and its antioxidant potential being the most important jewel within the product's composition. Products and entrepeneur opportunity presentations performed as well as marketing and leadership consultation.
Clinical Research Associate (CRA)
January 2010 --- September 2011
Working for ICON as CRA. My duties during this period has been to check that the studies developed at some hospitals are following the GCP/ICH indications as well as clinical trial protocol. Apart from this, I have to work very closely with the clinical trial sponsor and Ethical Comittee during all the phases along the clinical trial in order to obtain all the necessary documents to be submitted to Regularoty Health Authority and Ethical Comittees I've been working in Feasibilities, pre-study visits, monitoring visits, co-monitoring visits and close-out visits for some studies at different phases and for different therapies (feasibilities for oncology phase I and haemodynamics phase II studies, Pre-Study Visits for Pulmonary Arterial Hypertension phase I study, Monitoring visits and Close-Out visits for cardiology phase III study) Awarded with the SCRIP Clinical Research Team of the year for my participation on the TRACER Clinical Research Team as Clinical Research Associated. Awarded by ICON because of my performance during my participation on the TRACER study as Clinical Research Associated Mentoree task for junior CRAs in order to help them throughout their development in the company
Clinical Research Associate (CRA)
October 2006 --- January 2010
Monitor de ensayos clínicos (Clinical Research associate) en diversas áreas de salud como cardiología y neurología.
Clinical Research Associate (CRA)
September 2006 --- October 2006
Working as renting CRA for SERVIER Laboratories.
August 2005 --- August 2006
June 2004 --- September 2004
Helping in the dispensation and the pharmacy organization task (i.e: receipts organization, drugs distribution, marketing campaings...)
June 2003 --- October 2003
December 2001 --- August 2002
centres of Sol and Goya (Madrid)
Master of Business Administration (MBA) in from Universidad Camilo José Cela in 2015
Iridology approved course in Naturopathic Medicine/Naturopathy from ESCUELA SUPERIOR DE TÉCNICAS Y ESTUDIOS AVANZADOS in 2012
Bachelor of Pharmacy (BPharm) in Pharmacy from the School of Pharmacy at Complutense University from Madrid in 2006
licenciado in Farmacia from Universidad Complutense de Madrid in 2006
graduado in farmacia from Università degli Studi di Parma in 2005
in from Colegio Nuestra señora del Loreto in 2000
Training and Certification
English Dexway Let's Talk - Level C1 Certification