Clinical Research Manager I

4 semanas atrás

Santo Amaro, Bahia, 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. -Applicable to Clinical Scientific Expert IThe 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 to 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
**About the Role**:
**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.
- Applicable for Clincial Scientific Expert I: -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.
You'll receive: 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.
Division
Development
Business Unit
Innovative Medicines
Location
Brazil
Site
Santo Amaro
Company / Legal Entity
BR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.A
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No

  • Clinical Research Associate Ii

    3 semanas atrás

    Santo Amaro, Bahia, Brasil Novartis Tempo inteiro

    **Summary**:Site relationship management role to ensure sustainable trial execution at Site. Performs on-site and remote monitoring activities related to initiation, conduct and timely completion of Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs. Proactive...

  • Global Clinical Research Specialist

    1 semana atrás

    Santo Amaro, Bahia, Brasil beBeeClinical Tempo inteiro R$100.000 - R$150.000

    Global Clinical Trial ExpertWe are seeking a highly skilled and experienced professional to contribute to the success of our global clinical trial initiatives.Job DescriptionThe successful candidate will be responsible for contributing to all aspects of global clinical trial activities, including project management, coordination, and execution. This role...

  • Clinical Research Medical Advisor

    3 semanas atrás

    Santo Amaro, Bahia, Brasil Novartis Farmacéutica Tempo inteiro

    About the Role Key Responsibilities Validate study designs and assess trial feasibility based on clinical practice and competitive analysis. Drive fast and high-quality trial site start-up through expert input during planning phases. Provide clinical expertise for IRB/EC interactions and informed consent content. Develop trial plans that address recruitment...

  • CRA Senior

    2 semanas atrás

    Santo Amaro, Bahia, Brasil Healthcare Businesswomen's Association Tempo inteiro

    OverviewJob Description Summary -Planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. May interact with investigational sites, clinical consultants, Contract Research Organizations & other vendors. Collaborates with Country medical/clinical colleagues, global clinical teams and directs...

  • CRA Senior

    2 semanas atrás

    Santo Amaro, Bahia, Brasil Healthcare Businesswomen's Association Tempo inteiro

    Overview Job Description Summary -Planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. May interact with investigational sites, clinical consultants, Contract Research Organizations & other vendors. Collaborates with Country medical/clinical colleagues, global clinical teams and directs...

  • Study Start-up Clinical Research Associate

    3 semanas atrás

    Santo Amaro, Bahia, Brasil Novartis Tempo inteiro

    **Summary**:Site relationship management role to ensure sustainable trial start-up at Site.The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP,...

  • Sr Medical Manager for Oncology

    4 semanas atrás

    Santo Amaro, Bahia, Brasil Novartis Tempo inteiro

    **Summary**:Lead the development and execution of country Medical Affairs Plan. Be an accountable scientific partner communicating externally and internally. Keep up to date with key developments in own TA. Gather and share insights with global, region and country local stakeholders**About the Role**:**Key responsibilities**:- Develop and implement country...

  • Clinical Trial Associate

    4 semanas atrás

    Santo Amaro, Bahia, Brasil Novartis Tempo inteiro

    **Summary**:Na Novartis, nosso compromisso é reimaginar a medicina. Como Associado de Ensaios Clínicos (CTA), você será peça-chave no suporte ao Gerente de Início de Estudos da SSO e ao Gerente de Projetos Clínicos da SSO nos estudos designados. Você contribuirá durante a configuração e todo o ciclo de vida do estudo, garantindo conformidade com...

  • Medical Services Manager

    4 semanas atrás

    Santo Amaro, Bahia, 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 Model**:Hybrid**Locality**:...

  • Cell Therapy Center Director

    2 semanas atrás

    Santo Amaro, Bahia, Brasil beBeeOperations Tempo inteiro US$120.000 - US$150.000

    Job OverviewThe Cell Therapy Operations Manager plays a pivotal role in ensuring the successful launch and continued operation of CAR-T centers.This involves ensuring timely supply of high-quality starting material for manufacturing personalized CAR-T products, as well as providing seamless end-to-end operational customer support.About the RoleCommercial...