Maria Joao Santos

Biotecnologia e Farmácia

Lisboa

Sobre mim

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 UnitApril 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 PhaseMay 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.

Competências

Medical writing in different therapeutic areas - Co-development and revision of Protocols and Case Report Forms for effectivenesssafetysurveillancerisk managementutilization patterns and cost-effectiveness studiesdevelopment and revision of Patient Information and Informed Consent Forms.Management of regulatory authority applications and approvals - Submission to National Data ProtectionCompetent AuthorityEthic CommitteesRegional 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 personnelPharmaceutical IndustryPatients Health Associationspartner Contract Research Organizations located in different countries. Project management - Management of national and international project operationsdefinition of study timelines and milestonesmeetings and teleconferences leaderpresentation of project statuscreation of progress reports and newslettersdevelopment of strategiesidentification of problems/difficulties and suggestion of potential solutionsbudget controlquality 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

Experiência profissional

Biotecnologia e Farmácia

Formação académica

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 pr