Experience

ClinSearch

• Clinical Project Manager

  • Sep 2017 - Present

  • Management and coordination of the project activities to ensure consistently high performance according to the study budgets, timelines and resources.• Prepare and review study essential documents and procedures (Study reports, Clinical Monitoring Plan, Safety Management Plan,…)• CRA management, training and review of visit reports• Management of the study start-up activities in a proper timely manner: site feasibility studies, international regulatory affairs submissions (AC/EC),… • Management and coordination of the project activities to ensure consistently high performance according to the study budgets, timelines and resources.• Prepare and review study essential documents and procedures (Study reports, Clinical Monitoring Plan, Safety Management Plan,…)• CRA management, training and review of visit reports• Management of the study start-up activities in a proper timely manner: site feasibility studies, international regulatory affairs submissions (AC/EC), review and set-up of site Clinical Trial Agreements, study kick-off meetings…• Management and training of the clinical project team• Serve as Key Contact between the Sponsor, Investigators, Research Associates…• Ensure client satisfaction. Show more Show less



Ascopharm Groupe Novasco

• Regulatory Affairs Project Manager

  • Jan 2017 - Sep 2017

  • Prepare, review, submit and file clinical trial applications (CTA forms) to national regulatory Competent Authorities (France, Spain, Italy, UK…) and Ethic Committees.• Provide updated forecast of local submission and approval timelines.• Ensure submissions compliance with applicable regulations.• Collect the required investigator and regulatory documents from the sites ensuring documents meet the required specifications.• Clinical contracts management to negotiate and execute… • Prepare, review, submit and file clinical trial applications (CTA forms) to national regulatory Competent Authorities (France, Spain, Italy, UK…) and Ethic Committees.• Provide updated forecast of local submission and approval timelines.• Ensure submissions compliance with applicable regulations.• Collect the required investigator and regulatory documents from the sites ensuring documents meet the required specifications.• Clinical contracts management to negotiate and execute site-specific country template contracts.• Advise study team on changing regulations and compliance requirements.• Track submissions and ensure to meet the timelines. Show more Show less



FAES FARMA

• Regulatory Affairs Specialist

  • Sep 2016 - Dec 2016

  * Preparation of CTD Dossiers (Modules 2 and 3), including eCTD format.* Preparation of regulatory documents* Update and preparation of old CTD



iLine Microsystems

• Clinical Project Specialist

  • Jul 2013 - Aug 2016

  • Management, coordination and planning of clinical research: CEIC/IRB submissions, collaboration with external clinical sites, development of protocols, Informed Consent Forms and other study documents.• Research of national and international clinical sites. Contract negotiations.• Maintain quality system documentation in accordance with ISO 13485 and ISO9001.• Assist in Regulatory Compliance and product registration (EU, FDA, Brasil...).• Generating and maintaining Technical… • Management, coordination and planning of clinical research: CEIC/IRB submissions, collaboration with external clinical sites, development of protocols, Informed Consent Forms and other study documents.• Research of national and international clinical sites. Contract negotiations.• Maintain quality system documentation in accordance with ISO 13485 and ISO9001.• Assist in Regulatory Compliance and product registration (EU, FDA, Brasil...).• Generating and maintaining Technical Files in accordance with regulatory requirements. • Management of complaints, non conformities and corrective actions.. Show more Show less



Farmacia Arrechea. Cantabria

• Pharmacist

  • Jul 2011 - Aug 2016

  • To dispense medicines.• To use electronic prescription.• To use electronic programs SigeFar and Cifarma.• To give pharmaceutical advice to patients



Universidad de Navarra

• Masters student in the Department of Pharmacology and Toxicology

  • Sep 2011 - Dec 2012

  MSc student Research, Development and Innovation of new drugs. University of Navarra. Expected Completion Date: December 2012.



Hospital Comarcal de Laredo

• Hospital Nutritionist

  • Jul 2011 - Aug 2011

  • To elaborate diets for different pathologies.• To give dietician advice to the patient.• To call suppliers.



Psicogeriatrico San Francisco Javier

• Kitchen Nutritionist

  • Jun 2011 - Jun 2011

  • To cook different meals for special patients.• To collaborate with doctors in the elaboration of diets.• To review refrigerators and stores.



Clínica San Miguel

• Hospital Pharmacist

  • Jan 2010 - Jun 2010

  • To prepare drug carts.• To supervise medicines to patients.• To collaborate with doctors in some pathologies.