Clinical Research Manager I
2 semanas atrás
Job Description Summary
The professional will be responsible for contributing, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s) and is a core member of the Clinical Trial Team.
Applicable to Clinical Scientific Expert I
The Clinical Scientific Expert I (CSE I) provides clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D in compliance with Novartis processes, ICH GCP and regulatory requirements. This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated with trial endpoints and patient safety. The CSE I is a core member of the Clinical Trial Team (CTT) and may support program level activities as assigned.
This role will work directly with the SSO team: Clinical Research.
Work Model: Hybrid
Locality: São Paulo
Major accountabilities:
- Implementing issue resolution plans.
- Assist with program level activities (e.g., tracking of program).
- Managing interactions with relevant line functions including data management, drug supply management, clinical development and/or Novartis Country Pharma Organizations.
- Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.
- Distribution of marketing samples (where applicable).
- Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards.
- Proactive operational planning with effective contingency and risk mitigation plans.
- Performing clinical data review and insights consistently and accurately which meets the Novartis quality standards, timelines, and is inspection ready.
- High quality contributions to study documents (e.g. protocol, ICF, clinical sections of CTA).
- Clearly demonstrates Novartis Values and Behaviors (i.e. Innovation, Quality, Collaboration, Performance, Courage and Integrity).
Minimum Requirements:
Work Experience:
- Higher education in the area of Health.
- Experience as a Clinical Research required.
- Critical Negotiations.
- Advanced / Fluent English.
- Operations Management and Execution.
Skills:
- Clinical Research.
- Clinical Trial Protocol.
- Clinical Trials.
- Data Integrity.
- Learning Design.
- Lifesciences.
- Risk Monitoring.
- Trends Analysis.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us
Benefits: Competitive salary, annual bonus, life insurance, home office policy (home office 2x a week), retirement and wellbeing plans, flexible working arrangements, birthday day-off, parental leave, subsidized dining facilities, health insurance, employee recognition platform, Gympass, employee resource groups and virtual self-development tools.
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
#J-18808-Ljbffr-
Clinical Research Manager I
2 semanas atrás
Santo Amaro, Brasil Novartis Tempo inteiro**Summary**: The professional will be responsible for Contributes, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team....
-
Clinical Research Manager I
1 semana atrás
Santo Amaro, Brasil Novartis Farmacéutica Tempo inteiroThe professional will be responsible for contributing, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance, and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team. The Clinical...
-
Clinical Project Manager
6 meses atrás
Santo Amaro, Brasil Novartis Tempo inteiro**Summary**: The SSO Clinical Project Manager (CPM) at Novartis is responsible for the daily management, oversight and reporting of Global Drug Development (GDD) studies, ensuring compliance and acting as the main point of contact within the country/cluster/hub for these studies. The CPM coordinates with various team members and managers to execute studies...
-
Study Start-up Manager
4 meses atrás
Santo Amaro, Brasil Novartis Tempo inteiro**Summary**: The professional will be responsible for coordinating deliveries relating to start-up processes within the deadlines expected by the area. In this role, you will be responsible for coordinating deliveries relating to start-up processes within the deadlines expected by the area. This role will work directly with the SSO team: Clinical...
-
Clinical Operations Manager for Global Drug Development
4 semanas atrás
Santo Amaro, Bahia, Brasil Novartis Tempo inteiroJob DescriptionWe are seeking a highly skilled Clinical Operations Manager to join our team in Novartis Brazil. As a key member of the Study & Site Operations team, you will be responsible for the governance and oversight of study start-up activities.About the RoleThis role is accountable for supporting the country Study Start-Up strategy and prioritization...
-
Sr Field Medical Lead
6 meses atrás
Santo Amaro, Brasil Novartis Tempo inteiro**Summary**: - Lead scientific engagement with their Medical Experts. Implement clinical and educational strategies and respond to unsolicited medical enquiries. **About the Role**: **Major accountabilities**: - Engage with Medical Experts (MEs) to educate on medical/scientific information -Ensure appropriate identification/mapping of MEs/ Key Accounts...
-
Strategic Foresight Manager
6 meses atrás
Santo Amaro, Brasil Novartis Tempo inteiro**Summary**: We are seeking a highly motivated and insightful professional who possesses strategic foresight skills applied to the healthcare system and pharmaceutical industry. As a strategic foresight expert, you will play a crucial role in analyzing trends, anticipating potential disruptions, and developing innovative strategies that drive sustainable...
-
Customer Solution Manager
4 meses atrás
Santo Amaro, Brasil Novartis Tempo inteiro**Summary**: To be the point of contact for radioligand therapy in the states of Rio de Janeiro, Minas Gerais and Espírito Santo, contributing to our purpose of reimagining medicine to improve and extend people's lives. In addition, to engage and add value to our customers and patients by participating in the launch of the new platform in the Brazilian...
-
Study Start-up Team Lead
3 meses atrás
Santo Amaro, Brasil Novartis Tempo inteiro**Summary**: The SSO Study Start-Up Team Leadis accountable for the governance and oversight of a study start-up team in Study & Site Operations Novartis Brazil. This position is responsible to support the country Study Start-Up strategy and prioritization in close collaboration with Country Head to deliver operational excellence of the Global Drug...
-
Medical Services Manager
6 meses atrás
Santo Amaro, Brasil Novartis Tempo inteiro**Summary**: - Agile cross-functional collaboration to ensure we are prepared for strategic and frequently asked questions. -Continuously improving our reactive positionings according to their monitored effectiveness -Implementation of a lean but impactful process when dealing with non-prioritize portfolio **About the Role**: **Work...
-
Access & Heor Lead
3 semanas atrás
Santo Amaro, Brasil Novartis Tempo inteiro**Summary**: Leads the development and implementation of the patient accessstrategy at (large) country / regional level. To facilitate and achieve optimal Patient Access by building relationships with keyinfluencers and decision-makers at a local level. **About the Role**: **Key responsibilities**: - Be part of the brand core value team, working closely...
-
Access and Heor Lead
6 meses atrás
Santo Amaro, Brasil Novartis Tempo inteiro**Summary**: Novartis is among the world's leading pharmaceutical companies, always seeking to bring innovative products to patients quickly and effectively. As a global company, resources and learning opportunities at Novartis are also plentiful, involving both global and local cross-functional careers. As part of Novartis Brazil, you will have great...
-
Rwe Study
6 meses atrás
Santo Amaro, Brasil Novartis Tempo inteiro**Summary**: Modelo de Trabalho: Híbrido Localidade: São Paulo Sobre essa vaga: Estamos procurando um RWE Study & MAP Operation Analyst para nos ajudar a permanecer entre as principais empresas farmacêuticas do mundo, sempre buscando levar produtos inovadores aos pacientes de forma rápida e eficaz. Como uma empresa global, os recursos e as oportunidades...
-
Country Manager
Há 2 dias
Espírito Santo, Brasil CPL Aromas Tempo inteiro**Date**:Dec 19, 2024 **Location**: Vilassar, ES **Company**:CPL Aromas - Reports to: - General Manager - Job Purpose - This position is responsible for ensuring existing sales in the Italian market and increasing their volume, as well as being responsible for acquiring new customers to drive revenue growth and strengthen market leadership. This position...
-
Country Manager
Há 4 horas
Espírito Santo, Brasil CPL Aromas Tempo inteiroDate: Dec 19, 2024 Location: Vilassar, ES Company: CPL Aromas Reports to: General Manager Job PurposeThis position is responsible for ensuring existing sales in the Italian market and increasing their volume, as well as being responsible for acquiring new customers to drive revenue growth and strengthen market leadership. This position will also be...
-
Technology Manager
2 meses atrás
Espírito Santo, Brasil Royal A-ware Tempo inteiroAbout Royal A-ware We are a traditional family concern, with over 130 years of experience in the food business. With over 3,000 colleagues, we strive every day to produce the tastiest cheese, fresh dairy products, cream, tapas, and milk powder for the Netherlands and the rest of the world. You will find us to be a passionate business that can adapt quickly....
-
Pathways Leadership Internship Spain, Customer
2 meses atrás
Espírito Santo, Brasil Amazon Spain Fulfillment, S.L.U. - C05 Tempo inteiroCurrently enrolled in an MBA/PhD or graduate January 2025 onwards and available for 10-12 weeks between June and October to work full time - Between 3 and 10 years of complex professional experience (excluding internships and work studies) with responsibility for project management and delivery - Flexible to work in non-traditional shift patterns, which may...
-
Planejador(a) de Manutenção I
3 semanas atrás
Vitória de Santo Antão, PE, Brasil Mondelēz International Tempo inteiro**Are You Ready to Make It Happen at Mondelēz International?** **Join our Mission to Lead the Future of Snacking. Make It With Pride.** You have in-depth mastery of one technical process and maintains that process using progressive maintenance standards, troubleshooting on multiple processes and issues when necessary. You also lead at least one standard...
-
Planejador(a) de Manutenção I
Há 1 mês
Vitória de Santo Antão, PE, Brasil Mondelēz International Tempo inteiro**Are You Ready to Make It Happen at Mondelēz International?** **Join our Mission to Lead the Future of Snacking. Make It With Pride.** In this leadership role, you are an internal technical master at the line level who ensures the line team is performing at a level that sustains and improves business results on one or more of 6 stars model. You model...
-
Vaga De Gerente Unidade Servicos Integrados I
2 semanas atrás
Cabo De Santo Agostinho, Brasil Catho Online Ltda. - BR - Manager Tempo inteiroOportunidade de TrabalhoA Sodexo está em busca de nutricionistas com vivência em supervisão de contratos de facilities (limpeza e jardinagem) para atuar em Suape/PE.RequisitosConhecimento: Intermediário no pacote OfficeHabilidades: Gestão de UAN, resultados, liderança e gestão de equipeCaracterísticas Pessoais: Resistência à pressão,...