Clinical Operations Manager
Since April 2010
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 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.
Licenciatura in Farmacia from Universitat Autònoma de Barcelona in 2000