Education and Qualifications:
1999-2004 Degree in Pharmacy at University of Barcelona.
Complementary Education:
-20,27Sept, 04,25Oct and 08Nov2019:Certificate in Project Management in Clinical Research at CESIF (40h)
-20May-22May2019 Certificate in NEW EudraVigilance System and the electronic reporting
of ICSRs in the ISO/ICH E2B(R3) format at DIA EMEA
-01Jul-22Jul2016:Training course in Oncology Clinical Trials at Vall d’Hebron- Institut
d’Oncologia (40h).
-April2015-April 2016: Pharmacovigilance Postgraduate at IL3 (University of Barcelona)
-03Nov2015-01Dec2015: Specialist Certificate in Administrative Management Specialist in
Clinical Trials (CTA) at IUSC.
-Apr-Nov 2012 ICH-GCP online training at Universidad Autónoma de Madrid, Spain.
-Jan-Mar 2012 Pharmacovigilance Online Course at Instituto de
Farmacoepidemiologia (Universidad de Valladolid), Valladolid, Spain
-Jan-Feb 2012 ICH-GCP Training at Institut Universitari de Ciència i Tecnologia,
Barcelona, Spain.
- April-May 2010 Specialist Certificate in Administrative Management Specialist in
Clinical Trials (CTA) at Fundación Esame (45h).
- January 2010 Seminar: Legal and practical aspects of Clinical Trials and studies
post-authoritzation (update 2009) at Col·legi Oficial de Metges de
Barcelona.
-Feb-June 2009: Clinical Trial Monitoring online Course at Col·legi Oficial de Metges de
Barcelona
-March 2007 Clinical Trial Monitoring Course at Col·legi de Farmacèutics de
Barcelona.
-Sep2005- May2006 Upper-Intermediate/FCE certificate at London College Dublin.
-Summer of 1999 Typing Diploma at ESEC of Sabadell (Barcelona).
-Summer of 1999 Information Technology Diploma at ESEC of Sabadell.

Professional Experience:
-May 2014-Present: Position: Clinical Trial Manager/ Senior Clinical Research Associate
Location: Academic Research Organization (ARO),Vall d'Hebron Institut de Recerca (VHIR).
Duties: Involved in different Clinical trials (Areas: Oncology,Neurology, Hepatology, Medical Devices).
• Ensures full management of the study team and coordination of all sections involved in the project.
• Performs tracking and maintains customer contacts.
• Ensure the implementation of GCP and SOPs in clinical trials.
• Performs review of key project documents (protocol, CRF, data management plan, monitoring plan, amendments, etc..).
•Attends conferences, both national and international.
•Provides monitoring of clinical trials in accordance with the ICH Guidelines, GCP and SOPs, focusing on enrollment and quality of data.
• Performs Start-up, conducts initiation, monitoring and close out visits as well as prepares reports of the visits and maintains contacts with the participant sites.
•Performs onsite and remote monitoring visits
• Assist in the submission of all relevant study documents to the relevant ECs and Regulatory Authorities.
• Review of the TMF and Investigator File.
• Review and collect completed Case Report Form data, including source data verification.
• SAE review and reporting, ensures adverse events are reported properly, accurately and on time.
• Performs drug accountability, shipment and disposal from sites.
• Organizes blood samples shipment to Central laboratory and reconciliation.
• Assist in investigator/site contract preparation.
• Regular communication with Ethics Committees, Regulatory Authorities, if required.
• Problem-solving for questions or concerns of study sites.

-Aug 2012- Apr 2014: Position: Senior Clinical Research Associate.
Location: SynteractHCR Harrison Clinical Research Iberica, S.L, A SynteractHCR, Inc Company, Barcelona, Spain.
Duties: Involved in different Clinical trials (Areas: Oncology, Neurology, Medical Device, Urology)
• Assist in the submission of all relevant study documents to the relevant ECs and Regulatory Authorities.
• Review of the TMF and Investigator File.
• Arrange translation of study documentation.
• Review and collect completed Case Report Form data, including source data verification.
• Internal Quality Control of completed Case Report Form data.
• SAE review and reporting.
• Assist in investigator/site contract preparation.
• Coordinate investigator payments.
• Ensure all activities are conducted within budget requirements as instructed by the Project Manager.
• Main contact person for site personnel.
• Act as a link between HCR, investigator, subcontractors and sponsor as required.
• Regular communication with Ethics Committees, Regulatory Authorities, if required.
• Meet regularly with the PM or other relevant senior staff to provide an update of study progress at study sites and to review workload.
• Develop and maintain good professional relationships with past, current and potential clients of HCR, with site personnel and with different departments within the HCR group.
• Assist the PM to enable them to perform their role.
• Problem-solving for questions or concerns of study sites.

-March2008-Jul2012 Position: Project Manager/ CRA II of Secondary Prevention of Small
Subcortical Strokes Trial promoted by NIH (National Institute of Health)
Location: Fundació Idibell (Clinical Trial Departament).
Duties:
• Supervise and directly interact with the sites to assure the proper execution of the protocol.
• Communicate regularly with the Coordinating Center in Vancouver (Canada) in order to report the activities/progress/potential problems in the sites.
• Monitoring all sites in Spain. Visiting the sites as scheduled or as required.
• Data entry and randomization for all sites.
• Answering the queries on a timely manner and securing the correction of these in the CRF at the sites.
• Maintaining telephone communication with the sites as needed.
• Training and supervise any new personnel collaborating with the data entry.
• Maintaining a close communication with the Coordinating Center in Vancouver (Canada) regarding the daily base activities.
• Medication inventory updating and counting.
• Reporting SAE to the study Security Committee.
• Trial master file updating and legal documents.
• Maintaining a close communication with the Stadistic Center in Alabama and answering their queries reports

- Nov2007-Feb2008 Position: Training period as a CRA.
Location: Kendle International of Barcelona.
Duties:
• Helping to organize and coordinate initiation visits and monitoring visits of clinical trials (phase III-IV) according to company policies, SOPs, ICH GCP and regulatory requirements.
• Ensure investigator compliance with protocol, study procedures and timelines.

Personal Skills:
-Creativity and Initiative
-Ability to work independently/in team
-Good organizational, communication and interpersonal skills.
-Computer knowledge
-Availability to travel