CV

• 5 years’ experience in Clinical Research.
• Management/Collaborations in more than 10 European studies (Phase I-IV) with emphasis on planning and execution of projects with a core function in identification of potential and actual issues with impact on successfully delivery of projects, ensuring solutions are implemented to prevent extension to timelines/budget or reduction of targets and quality.
• Analysis, interpretation and preparation of data for presentation at scientific meetings.
• Writing and submitting material for publication as abstracts and full papers to peer reviewed journals.
• Training members of staff on clinical pathologies, experimental procedures and statistical analysis.
• Knowledge of International Conference on Harmonisation (ICH), Good Clinical Practice (GCP), EU Directive and other Regulatory guidelines.
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• Co-ordination of the setting up, running and reporting of the Stability Programmes for Europe and US products.
• Liaison with different laboratories and co-ordination of a variety of teams to provide consistency of the routine and technical studies as well as clinical trials.
• Quality Control of the GMP - Regulatory documentation related to Stability Studies, including SOPs, production of reports, protocols and deviation reports using the appropriate techniques of statistical analysis.
• Co-ordination of companies’ inspections, self-inspection audits and MHRA audits, ensuring that the systems are fit for purpose.
• Working closely with the GMP and QA team to ensure a consistency of systems approach between the two activities.
• Review and advice on Clinical Data Bases for the Clinical Trials.
• Control of all GCP - Regulatory documentation related to Clinical Trial studies in the company.
• Document translations and contacting of European sites.
• Co-ordination of the setting up, running and reporting of Clinical Trials on the Validation and reliability of the Spanish version of the DN4 questionnaire.
• Patient Selection and Recruitment, Psychological and Neurological examination and questionnaires. Supervising patients’ medication from the clinical records and interviews.
• Supervision and co-ordination of the clinical reports and presentations for publishing.
• Conducted and controlled main studies from handover to completion; Monitoring nation-wide clinical trials and associated institutions and areas (co-ordination with Pfizer, Cajal Institute (Madrid), SESCAM (Castilla La Mancha), Hospital Clinic (Barcelona), and University of Valencia). Projects: 4 years maximum to completion (target was exceeded). Number of patients: 100.
• Assisting in the updating and maintenance of the SOP system to ensure maintained compliance with GCP and European regulatory guidelines and legislation, and improving laboratory effectiveness, estimating costs of projects, trials, and record spends during projects.
• Production of Clinical Trial Plans, Protocols, CRFs, questionnaires for the patients and all the needed trial related paperwork, including the internal/ external approvals.
• Pharmacovigilance (clinical records, interviews; including Psychiatric pharmacy).
• Data Management, Statistical Data Analysis and Interpretation.
• Writing and co-ordinating the clinical findings and presentations for publishing (Cajal Institute (Madrid), SESCAM (Castilla La Mancha), Hospital Clinic (Barcelona), University of Valencia, Pain Relief Foundation, Aintree Hospitals, (Liverpool)).
• Mentored and trained of contracted and site staff in the Foundation and Hospital and visitor institutions within ICH / GCP guidelines, and trial related processes and procedures (physicians, doctors, nurses and students), provided assistance and advice on clinical staff recruitment.
• Clinical Psychologist at the Pain Unit and Spasticity Clinic in the Hospital.
• Techniques/ medical devices developed in Clinical Pain Diagnostics: VAS, VDS, and Quality of Life Questionnaires: MPI-SCI, CSQ. Pain Psychophysics: Bedside Sensory Testing, Quantitative Sensory Testing (QST), Thermal stimulation and Psychophysics. Laboratory pain tests with animals (von Freys, Hot Plate, Labyrinths, etc).

Employment History

Education