Manuela Campos
Associate Director- Gcp Process Excellence, Compliance & Inspection Strategy at Takeda
Based in São Paulo, Brazil
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Seniority
Director
Department
Manufacturing & Production
Location
São Paulo
Industry
Pharmaceutical Manufacturing
Company size
37K
Contact information
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m•••••••@takeda.com
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Background
About Manuela Campos
Pharmacyst with professional experience in the National and International Pharmaceutical Market, particulary in a Pharma and Vaccine Clinical Research Unit with strong performance in the Clinical Operations field from phase 2-4 studies, in Epidemiology, Clinical Operations Management, Quality and Training areas. • Expertise in different therapeutic fields - Metabolic, Respiratory, Oncology, CNS, HIV, Pharmacogenetics and Vaccines. • Huge experience in a Clinical Trial Materials Logistic processes set-up (import, distribution, pick-up and destruction) ensuring a proper CTM management and supply in the study sites with focus firstly in the patient. • Strong experience in Clinical Operations Management having special focus in the following aspects: Budget Management (IPE/EPE), Resources Management, People Development, Clinical Trial projects strategic management (Timelines, Financial and legal aspects, Risk Management, Recruitment and Enrollment strategies and targets, surveillance aspects, study data monitoring and quality), new projects allocation strategically aligned with the local market objectives - feasibility processes. • Leadership of multicultural teams, strategic vision, crisis management potential, great communication skills, focus on people development and continuous improvement. • Solid experience in designing and implement Clinical Research processes (SOPs) for Brazil and Southern Cone Countries, with focus in LEAN aspects (simplification and standardization) and in a continuous improvement. • Strong experience in develop and implement a training model (induction and mantainance) and a quality control system for Brazil and Southern Cone Countries, adopting creative and cost-efficient solutions, ensuring a high standard of quality on clinical trials conduction. • Fluent in English and Spanish. Specialities: Clinical Development, Project and People management, Quality and Training Management, Multicultural environment
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