SYNVIA

• Serve as the technical reference for the project, supporting the planning and execution of monitoring strategies. • Conduct monitoring of high-complexity sites, high-recruiting sites, or sites with a history of critical deviations. • Perform in-depth assessments of site performance and support the implementation of corrective and preventive actions (CAPAs). • Collaborate with the Project Manager in defining, reviewing, and tracking the monitoring plan. • Review monitoring reports from less-experienced CRAs to ensure standardization and quality. • Prepare sites for audits and regulatory inspections (ANVISA, FDA, EMA), providing technical guidance. • Identify operational risks and propose mitigation strategies to ensure adherence to timelines, data quality, and participant safety. • Conduct technical training sessions, initiation visits, and internal training activities for new CRAs. • Support supplementary study activities such as eTMF review, regulatory support, and alignment with the sponsor on operational deliverables. • Maintain senior-level communication with internal and external stakeholders, representing the monitoring function as needed.

• Conduct literature searches and reviews; • Draft and/or review clinical protocols and supplementary documents for bioequivalence / relative bioavailability studies; • Prepare the complete project dossier for submission to the CEP/Conep system via Plataforma Brasil; • Prepare amendments, notifications or responses to queries issued; • Prepare interim and final study reports; • Contribute technical responses to requirements issued by the competent authorities; • Stay up to date with applicable regulations and technical requirements.

• Handle sponsors’ requests with the required level of detail and grounded in current legislation; • Participate in discussions to define the best strategy for different projects; • Assist in project feasibility assessments; • Help identify potential risks/opportunities for projects in case of changes to applicable legislation and/or requirements; • Perform literature searches to prepare clinical study documents, regulatory-scientific opinions, systematic literature reviews and Investigator Brochures; • Prepare study protocols and documents related to clinical studies; • Draft Investigator Brochures; • Prepare systematic literature reviews; • Write and evaluate clinical and non-clinical modules (CTD format) of documentation for marketing authorization and post-authorization of medicines; • Revise and adapt prepared documents, when necessary, after review by project stakeholders; • Compile complete project dossiers for submission to the Ethics Committee system (CEP/CONEP) via Plataforma Brasil; • Prepare amendments, notifications, interim reports, protocol deviations or responses to deficiencies issued by the CEP/CONEP system; • Respond to internal monitoring/audits conducted by the Quality Assurance department; • Contribute technical responses to requirements issued by competent authorities; • Archive research project documents according to internal procedures; • Maintain the project database up to date according to internal procedures; • Write and/or review Standard Operating Procedures relevant to the department and assist, if necessary, in managing the department training matrix; • Support other analysts in the department; • Attend Regulatory and Scientific Affairs meetings and other meetings when requested; • Participate in technical meetings with sponsors and regulatory agencies together with the Regulatory and Scientific Affairs Management, when necessary; • Stay up to date with regulations and technical requirements applicable to the Brazilian regulatory authority and international guidelines for planning, conducting and submitting projects; • Represent the company before professional associations and participate in specific technical working groups when the topic has significant impact for the company and/or sponsors.

• Conduct monitoring visits (Site Qualification Visit – SQV, Site Initiation Visit – SIV, Interim Monitoring Visit – IMV, and Close-Out Visit – COV) according to the monitoring plan. • Perform on-site and/or remote monitoring, ensuring the study is conducted in compliance with the protocol, ICH-GCP, SOPs and local regulations. • Verify source data (SDV/SDR) and ensure the quality, integrity and traceability of clinical data. • Identify protocol deviations, inconsistencies and operational risks, supporting the implementation of corrective and preventive actions (CAPA). • Participate in clinical studies including bioequivalence, pharmacokinetics (PK), pharmacodynamics (PD) and Phase 1 studies, paying attention to the operational particularities of these designs. • Ensure sites are appropriately trained on the protocol, study procedures and systems used (eCRF, IWRS, eTMF). • Review and follow up on eCRF completion, and support query resolution with sites. • Ensure proper management of the Investigational Product (IP), including storage, dispensing, accountability and reconciliation. • Maintain the TMF/ISF up to date, ensuring document completeness and compliance. • Develop and maintain a professional relationship with investigators and site staff. • Proactively communicate study status, risks and issues to the Project Manager and other stakeholders. • Prepare monitoring reports and associated documentation within expected deadlines and quality standards. • Support start-up processes (when applicable), including collection of regulatory documents and site feasibility. • Provide support during audits and regulatory inspections.

• Conduct trainings relevant to your role and keep records up to date; • Manage clinical projects requiring interaction with various groups: multidisciplinary teams, data management, start-up, transportation/logistics, regulatory affairs, and quality assurance throughout the project lifecycle; • Provide comprehensive, strategic support for all project management activities; • Define and manage project scope, timelines, and deliverables from project initiation through close-out, ensuring the project plan is aligned with contractual requirements and addressing any necessary reconciliations; • Schedule, plan, and document meetings with sponsors and the project team. Assess project issues and propose resolutions to the team, Head of Clinical Operations, and the sponsor; • Assess project issues and propose resolutions to the team, Head of Operations, and the sponsor; • Support the procurement department in sourcing, identifying, and qualifying vendors/suppliers; • Identify and select research sites for project execution; • Support the commercial and operations departments during the feasibility phase of clinical trials; • Review commercial proposals related to clinical trials; • Review and manage contracts with research sites and vendors; • Attend initiation visits and, when necessary, site qualification visits, routine monitoring, and close-out visits at research sites; • Participate in the preparation and review of project-related documents, including: budget, protocol, Informed Consent Form (ICF), Case Report Form (CRF), site qualification reports, monitoring reports, among others; • Develop and implement corrective actions necessary to maintain project quality; • Responsible for clinical trial training of the Synova team involved in the project; • Develop study documents, including but not limited to: Project Management Plan, Pharmacovigilance Plan, Risk Management Plan, Monitoring Plan, Partner Management Plan, Pharmacy Manual, Laboratory Manual; • Supervise team members remotely and on-site; • Participate in the preparation and review of project-related documents, including: budget, protocol, informed consent form, forms, CRF, site qualification reports, monitoring reports, among others; • Support the development of clinical research analysts; • Ensure control of the study budget.

• Tratar as demandas dos patrocinadores com o detalhamento exigido e embasamento na legislação vigente; • Participar das discussões para definição da melhor estratégia para os diferentes projetos; • Auxiliar no processo de viabilidade dos projetos; • Auxiliar na identificação de eventuais riscos/oportunidades para os projetos quando da mudança da legislação e/ou requerimentos aplicáveis; • Realizar levantamento bibliográfico para a elaboração dos documentos dos estudos clínicos, pareceres regulatórios-científicos, Revisões Sistemáticas da literatura e Brochuras do Investigador; • Elaborar os protocolos e documentos relacionados aos estudos clínicos; • Elaborar Brochuras do Investigador; • Elaborar Revisões sistemáticas da literatura; • Escrever e avaliar os módulos clínicos e não clínicos (formato CTD) de documentação para registro e pós-registro de medicamentos; • Adequar os documentos elaborados, quando necessário, após a revisão das partes envolvidas no projeto; • Preparar o dossiê completo dos projetos para a submissão ao Sistema CEP/CONEP por meio da Plataforma Brasil; • Preparar emendas, notificações, relatórios parciais, desvios de protocolos ou respostas às pendências emitidas pelo Sistema CEP/CONEP; • Responder monitorias/auditorias internas realizadas pelo departamento de Garantia da Qualidade; • Contribuir com as respostas técnicas às exigências exaradas pelos órgãos competentes; • Arquivar os documentos dos projetos de pesquisa conforme procedimentos internos; • Manter o banco de dados dos projetos atualizado conforme procedimentos internos; • Escrever e/ou revisar Procedimentos Operacionais Padrão pertinentes ao departamento e auxiliar, se necessário, no gerenciamento da matriz de treinamentos da área; • Auxiliar os demais analistas do departamento; • Participar das reuniões da área de Assuntos Regulatórios e Científicos e sempre que solicitado; • Participar de reuniões técnicas com os patrocinadores e órgãos reguladores junto à Gerência de Assuntos Regulatórios e Científicos, quando necessário; • Manter-se atualizado frente aos regulamentos e requisitos técnicos aplicáveis à agência regulatória brasileira e guias internacionais para planejamento, condução e submissão dos projetos. • Representar a empresa junto às entidades de classe e participar de grupos técnicos específicos quando o tema for de grande impacto para a empresa e/ou patrocinadores.

• Handle sponsors’ requests with the required level of detail and grounding in current legislation; • Participate in discussions to define the best strategy for different projects (clinical research and products); • Assist in the feasibility assessment of various projects; • Identify potential risks and opportunities for projects arising from changes in legislation and/or applicable requirements; • Perform critical review of technical dossiers for purposes of registration and post-registration of medicines in Brazil; • Prepare and review documents, including compiling clinical research dossiers for different categories of medicinal products for submission to Anvisa; • Conduct due diligence of regulatory documentation; • Prepare regulatory opinions and scientific regulatory reports; • Assist in the design and discussion of the clinical development plan for an investigational product; • Prepare technical responses to requirements issued by the competent authorities; • Monitor publications of interest to the company and/or sponsors in the Official Gazette of the Union (Diário Oficial da União); • Stay up to date with regulations and technical requirements applicable to the Brazilian regulatory agency and international guidelines for planning, conducting and submitting projects; • Participate in specific technical working groups of external organizations when the topic has a significant impact on the company and/or sponsors.

• Act as a technical reference on the project, supporting the planning and execution of monitoring strategies. • Conduct monitoring of high-complexity sites, high-recruiting sites, or sites with a history of critical deviations. • Perform in-depth site performance assessments and support the implementation of corrective and preventive actions. • Collaborate with the Project Manager to define, review, and follow up on the monitoring plan. • Review monitoring reports from less experienced CRAs, ensuring standardization and quality. • Prepare sites for audits and regulatory inspections (ANVISA, FDA, EMA), providing technical guidance. • Identify operational risks and propose mitigation strategies to ensure adherence to timelines, data quality, and participant safety. • Lead technical training sessions, initiation visits, and internal training activities for new CRAs. • Support complementary study activities, such as eTMF review, regulatory support, and alignment with the sponsor on operational deliverables. • Maintain senior-level communication with internal and external stakeholders, representing the monitoring function when required.

• Gerar listas de randomização de estudos clínicos e farmacodinâmicos/farmacocinéticos, bem como a documentação associada (procedimentos, programação e relatórios de sign-off), de acordo com Plano de Análise Estatística (PAE), SOPs e diretrizes do projeto; • Programar scripts estatísticos, principalmente em linguagem R, para análise de dados, geração de outputs e suporte a atividades de controle de qualidade; • Executar análises estatísticas de estudos clínicos e farmacodinâmicos/farmacocinéticos conforme protocolo e PAE, garantindo rastreabilidade, qualidade e aderência aos prazos contratuais; • Elaborar relatórios estatísticos do estudo, incluindo descrição metodológica e apresentação de resultados, conforme PAE, sob supervisão técnica; • Executar atividades de controle de qualidade (CQ) estatístico das análises realizadas, incluindo a elaboração de relatórios de CQ operacional, sob revisão e aprovação do estatístico sênior ou especialista; • Contribuir para a elaboração e revisão de documentos estatísticos do estudo, incluindo seções do protocolo clínico, PAE e sinopses de estudos, sob supervisão; • Apoiar o desenvolvimento do racional estatístico para sinopses e protocolos clínicos (Fases I, II, III e IV), com base em diretrizes e decisões metodológicas previamente definidas pela liderança estatística; • Realizar cálculos de tamanho amostral com base nos desfechos primários definidos em protocolo, sob orientação metodológica; • Interagir com equipes internas da CRO (Data Management, Clínica, Programação Estatística, Qualidade e Gerenciamento de Projetos) para garantir consistência entre dados, análises e documentação; • Participar de reuniões técnicas com patrocinadores, quando aplicável, apresentando e esclarecendo resultados estatísticos sob supervisão.

• Independently conduct qualification, initiation, routine monitoring, and close-out visits at higher-complexity sites. • Perform source data verification and review documentation to ensure data integrity, accuracy, and consistency. • Monitor adverse events and collaborate with the study safety team when necessary. • Assess site regulatory documentation and ensure ongoing compliance with protocol requirements and regulatory authorities. • Assist in resolving operational issues and study deviations together with the Project Manager. • Support underperforming sites by tracking corrective and preventive actions; report and manage protocol deviations. • Train site teams on study-related topics, tools, and operational activities. • Assist in the training and co-monitoring of junior CRAs. • Maintain clear and continuous communication with stakeholders, internal teams, and sponsors.