• Develops clinical roadmaps for specific application areas based on healthcare trends and market insights. • Provides expert input to support product strategy, marketing decisions, and clinical policy development. • Bridges market needs and internal teams by identifying unmet clinical demands and promoting best practices and success stories. • Participates in the development of comprehensive clinical roadmaps for specific application areas. • Participates in marketing and development strategy meetings, contributing expert insights on product policies and clinical trends. • Facilitates the sharing of successful or innovative projects. • Communicates unmet clinical needs of the local market to internal teams. • Presents clinical research findings and innovative project outcomes during customer presentations. • Evaluates emerging medical technologies and clinical applications. • Collaborates with R&D, marketing, sales, and service teams.

• Lead complex studies such as NDA submissions or multi-protocol programs, coordinating activities across locations. • Perform project management activities including resource planning, timelines, and milestone management. • Serve as DMC Support Statistician, developing Charters and attending DMC Meetings. • Lead development of Statistical Analysis Plans, perform senior reviews of plans developed by others. • Conduct statistical review of TFLs for complex studies prior to delivery. • Review study-specific specifications. • Provide mentoring and training to less experienced staff. • Present knowledge at seminars and external meetings. • Attend bid defense meetings for complex studies. • Represent the department during audits.

• Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines. • Provide medical care to patients, always ensuring patient safety comes first. • Perform all defined study activities (i.e., informed consent, screening, and protocol procedures which include but are not limited to vital signs, pregnancy tests, height, weight, ECGs, blood draw, etc.). • Record all patient information and results from tests as per protocol on required forms. • Complete IP accountability logs and associated information when required. • Report suspected non-compliance to relevant site staff. • Ensure that IRB approval is obtained prior to study initiation and that IRB requirements are met throughout the study. • Promote the company and build a positive relationship with patients to ensure retention. • Attend site initiation meetings and all other relevant meetings to receive training on the protocol. • Call patients, handle patient bookings, and perform follow-up calls when required to confirm bookings or provide information or results. • Log and complete information on sponsor systems, ensuring accuracy (i.e., case report forms, EDC, etc.) and timely completion. • Gather source documents, update patient files and notes, always ensuring relevant and up-to-date information is recorded. • Adhere to company COP/SCOP. • Dispose of waste according to standards and assist in maintaining a neat appearance of the facility when required.

• Executar visitas de monitoria (Site Qualification Visit – SQV, Site Initiation Visit – SIV, Interim Monitoring Visit – IMV e Close-Out Visit – COV), conforme plano de monitoramento. • Realizar monitoria on-site e/ou remota, garantindo a condução do estudo em conformidade com protocolo, ICH-GCP, SOPs e regulamentações locais. • Verificar dados fonte (SDV/SDR) e assegurar a qualidade, integridade e rastreabilidade dos dados clínicos. • Identificar desvios de protocolo, inconsistências e riscos operacionais, apoiando na implementação de ações corretivas e preventivas (CAPA). • Atuar em estudos clínicos incluindo Bioequivalência, Farmacocinética (PK), Farmacodinâmica (PD) e estudos de Fase 1, com atenção a particularidades operacionais desses desenhos. • Garantir que os centros estejam devidamente treinados no protocolo, procedimentos do estudo e sistemas utilizados (eCRF, IWRS, eTMF). • Revisar e acompanhar o preenchimento de eCRFs, bem como apoiar na resolução de queries junto aos centros. • Assegurar o adequado gerenciamento do Produto Investigacional (IP), incluindo armazenamento, dispensação, accountability e reconciliação. • Manter o TMF/ISF atualizado, garantindo completude e conformidade documental. • Desenvolver e manter relacionamento profissional com investigadores e equipes dos centros. • Comunicar de forma proativa o status do estudo, riscos e issues ao Gerente de Projeto e demais stakeholders. • Elaborar relatórios de monitoria e documentação associada dentro dos prazos e padrões de qualidade esperados. • Apoiar processos de start-up (quando aplicável), incluindo coleta de documentos regulatórios e viabilidade de centros. • Dar suporte durante auditorias e inspeções regulatórias.