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Experiences

Current Experience

  • Clinical Operations Manager


    Since April 2010

  • SCRA


    Since December 2008
    overall site management of Clinical trials: regulatory activities.compilation of Ethics submissions, Investigator selection, site selection and initiation, Contract Management, agreements between sponsor, institution and third parties, monitoring through to close-out all in accordance with ich-gcp. datamanagement and study Coordinator services. maintenance of study files, follow-up of serious Adverse Events and endpoints. Pharmacovigilance database. review progress of project and achieve target objectives science)" rel="nofollow">Protocol design, crf, Informed Consent design and set-up all parts involved in the Clinical trials and post-authorization studies. strong understanding of current industry regulations: ich-gcp, cgcp, glp, emea region FDA region last gcp Training october 2014. working in the construction of eCRF ( clinical database Software) with redsauce s.l. the Software can be used in Phase I-iv Clinical trials. working in Contract Management with the law firm contract specialist in Clinical research. conducting studies Phase I- iv, oncology, Cardiology, urology, ncs, uci, Vaccines, digestive disease, Immunology, obesity, infection disease, Diabetes, Hypertension, arthritis, pneumonology, anemia. Overall site management of clinical trials: Regulatory activities.compilation of Ethics submissions, investigator selection, site selection and initiation, contract management, agreements between sponsor, institution and third parties, monitoring through to close-out all in accordance with ICH-GCP. Datamanagement and study coordinator services. Maintenance of study files, follow-up of serious adverse events and endpoints. Pharmacovigilance database. Review progress of project and achieve target objectives Protocol design, CRF, Informed Consent design and set-up all parts involved in the clinical trials and post-authorization studies. Strong understanding of current industry regulations: ICH-GCP, cGCP, GLP, EMEA Region FDA region Last GCP training October 2014. Working in the construction of eCRF ( clinical database software) with Redsauce S.L. The software can be used in phase I-IV clinical trials. Working in contract management with the law firm contract specialist in clinical research. Conducting studies Phase I- IV, oncology, cardiology, urology, NCS, UCI, vaccines, digestive disease, immunology, obesity, infection disease, diabetes, hypertension, arthritis, Pneumonology, anemia.

Knowledge

LinkedIn Assessment :
Asuntos normativosEnsayos clOncologVacunasIndustria FarmacOperaciones clBuena prOrganizaciNormas ICH de buenas prInvestigaciBiotecnologFarmacovigilanciaCardiolog

Education

  • Licenciatura in Farmacia from Universitat Autònoma de Barcelona in 2000

Area / Region

Barcelona, España

Others

Driving License
  • No

Other Candidates in Spain

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