• 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.

Role Description To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Trial IWRS Monitor for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy. - Act as a lead and primary contact with the client, building and maintaining relationships through work deliveries, solution designs, issue resolution, and escalations. - Act as primary contact with CTT Users for the Everest IWRS/IRT and eDiary team via the CTT Helpdesk telephone or Helpdesk email accounts. - Support client request and issue analysis, problem solving, and resolution, working closely with CTT Developers, internal Everest Data Management, Clinical Operations, Project Management, Quality and Compliance, and Statistical and Programming teams. - Perform medium-complexity drug management analysis and forecasting as required to ensure site and study drug inventory is managed effectively. - Monitor data generated within CTT to ensure accuracy and quality, including daily checks of automated data queries and weekly manual checks of the data generated from the system. - Coordinate and verify changes to the database and application using appropriate change control procedures, ensuring comprehensive and accurate documentation is completed. - Act as off-hours escalation point for junior CTT Clinical Monitor resources or the outsourced call center service to resolve high urgency client requests. - Monitor all studies involved with CTT to ensure accuracy and quality of the data, including the development of SAS checks for CTT applications. - Manage risks, issues, and escalations and work with teams in identifying mitigation/remediation options. - Perform final review and quality control checks and verification on junior CTT monitors work assignments. - Provide excellent client service and support during start-up activities, demonstrating subject matter knowledge and providing guidance and advice on solution designs and processes. - Generate, maintain, and/or review CTT Requirements Specification documents. - Develop CTT study test plans for newly developed projects or perform User Acceptance Testing (UAT) on newly developed projects with CTT. - Execute CTT application test planning, test plan and test script development, and Stage I and II testing activities for CTT applications. - Generate, maintain, and/or review Quick Reference Guides for all CTT studies. - Conduct IWRS demonstrations to Sponsors, as well as training demonstrations to study team members. - Support communications and coordination with Sponsors, Study Team Members, Depot personnel, and internal Everest data management and statistical leads across the CTT development lifecycle. - Drive, collaborate, and support, when required, data management, quality assurance (QA) personnel in performing QA procedures on CTT applications. - Analyze CTT monitoring and support trends to identify new CTT core features which will improve efficiency, effectiveness, user satisfaction, and market competitiveness. - Provide analytical, report generation, and project execution support to CTT and Everest management team members for internal CTT product/capability development initiatives. - Lead and support ad hoc business development initiatives for the CTT unit. - Drive, develop, and recommend the development of new CTT-related SOPs, processes, and procedures. - Train, manage, and mentor junior CTT monitors on monitoring and training activities. Qualifications - A bachelor's degree in health science, physical or biological fields, or computer science. - At least five years of experience in clinical trial data processing and management. - Experience in clinical research, call center support, pharmaceutical sciences. - Ability to think on the spot and apply critical thinking skills to triage user issues and formulate optimal responses. - Ability to effectively and appropriately interact with clients and Everest internal staff via phone and written email communications. - At least four or more years of experience in clinical trial data processing, technology delivery, process analysis and design, software development lifecycle, software testing, and project management. - Experience with client relationship management. - Comfortable using web application technologies and has prior customer service/support experience. - Comfortable with technology and web-based tools. - Excellent voice, courtesy, and interpersonal communication skills that provide an exceptional customer service experience. - Aptitude to learn and retain CTT application rules and support procedures. - Adaptive to varying customer knowledge and skill levels. - Adhere to all company security and privacy standards, and other policies and SOPs. - Good organizational skills and the ability to handle multiple tasks. Benefits - Robust benefits package including medical, dental, and vision coverage. - Life & AD&D insurance. - Short- and long-term disability. - Tuition reimbursement. - Fitness reimbursement. - Employee assistance program (EAP). - Pension plan. - Generous paid time off and sick leave. - Opportunity to earn a performance-based bonus.