Profissional
Experiência Profissional
Eurotrials, Scientific Consultants, S.A., Lisbon, Portugal:
March 2013 - June 2014: Project Manager and Line Manager of the Epidemiology & Late Phase Research Business Unit
April 2012 - February 2013: Senior Clinical Research Associate (CRA) – Late Phase
March 2009 – March 2012: Clinical Research Associate (CRA) – Late Phase
September 2008 – February 2009: Initiated specific training programme for Clinical Research Associate (CRA) – Late Phase
May 2007 – August 2008: Data-entry and Study Coordinator for Amgen Biofarmacêutica, Lda (outsourcing)
Educação e formação
Pre-Bologna Degree: Applied Chemistry – Biotechnology Specialization (2006) on Faculdade de Ciências e Tecnologia da Universidade Nova de Lisboa (FCT-UNL), Portugal, final grade of 14 (out of 20).
Courses:
Project Management (20h, 2010): Fundamentals of project management; Leadership and team management; Quality and project risk management; Financial management; Operational project management; Project management tools.
English Threshold Level of Wall Street Institute course (2009)
Food Hygiene and Safety/Implementation of Hazard Analysis and Critical Control Point (HACCP) (30h, 2007): Audits, Public health, Hygiene and food handling; Sanitization and hygiene, Food quality and safety.
Aptidões e competências pessoais
Medical writing in different therapeutic areas – Co-development and revision of Protocols and Case Report Forms for effectiveness, safety, surveillance, risk management, utilization patterns and cost-effectiveness studies; development and revision of Patient Information and Informed Consent Forms.
Management of regulatory authority applications and approvals – Submission to National Data Protection, Competent Authority, Ethic Committees, Regional Health Administrations and Hospitals’ Administration Boards for implementation of late-phase studies.
Good communication and liaison (national and international) – Contact with Investigators and other study personnel, Pharmaceutical Industry, Patients Health Associations, partner Contract Research Organizations located in different countries.
Project management – Management of national and international project operations, definition of study timelines and milestones, meetings and teleconferences leader, presentation of project status, creation of progress reports and newsletters, development of strategies, identification of problems/difficulties and suggestion of potential solutions, budget control, quality control and involvement in Standard Operating Procedures (SOPs) writing.
Coordination and supervision – Ensure under direct line management responsibility that staff metrics and objectives are clear and achieved. Assessment of metrics according with Business Unit and Company objectives. Ensure that staff complies with regulations, specifications and SOPs and follow-up on corrective and preventive actions.
Training skills – Attendance and active preparation of internal and external training activities, project and job specific. Staff training and continuous coaching.