Fernanda Vale

Background

About Fernanda Vale

Championing the patient and caregiver experience in every clinical trial design, study execution to decrease patient burden, increase patient satisfaction and improve the patient's overall clinical trial journey. • Global Patient Engagement Lead in Medical Operations: Implementing the patient voice into clinical development in all development phases (I to IV). • Collaboration with Global and Local Public Affairs & Advocacy, Medical Affairs, Regulatory, Patient Advocacy Groups to play an important part in the development and optimization of protocols to the patients, fit for proposal and spread clinical research educational concept; • ROI in the Patient Centricity and debates of Social Responsibilities Acting; • Site Partnership Manager working with Premier Sites • Evidenced large experience on planning, selecting, initiating, monitoring and close-out activities in Mega Trials and phase II & international studies, IV and observational studies according to ICH/GCP and Local Regulations for different areas: Cardiovascular, Oncology, Diabetes, Rheumatoid arthritis, Respiratory, Pediatric and Rare Diseases; • Evidenced large experience on budget construction, negotiation, control and management of local and global budgets; • Study Desing Team manager in charge of Interfacing with launch excellence, innovation, PMO and medical affairs franchises to align clinical studies strategy for new launches, established products and generics; • Experience in implementing strategies and CAPA Plans focused on results; • Supporting the ethics, regulatory submission and health authority application preparation according to IRB, National IRB (CONEP) and MoH (ANVISA) regulations; • Management of monitoring teams by defining KPIs and responsibilities related to the studies; • Organization and participation in International & Local Investigator’s meetings; • Experience in International audits; • Team Buildings preparations and participation; • Soft Skills: Communication, negotiations, emotional intelligence, problems solving and decision taken; Strenghts: Extremely committed, diligent, resilient, result-oriented and team-player.