Clinical Research Manager I

Há 2 dias

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. -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 Manager I

    3 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...

  • Senior Clinical Research Manager

    Há 6 dias

    Santo Amaro, Bahia, Brasil beBeeClinicalResearch Tempo inteiro R$90.000 - R$130.000

    Senior Clinical Research ManagerClinical trials are a crucial part of medical research. As a senior clinical research manager, you will play a key role in planning, executing, and interpreting these trials.Develop and implement trial protocols to ensure high-quality data collection.Collaborate with investigative sites, consultants, Contract Research...

  • Clinical Research Specialist

    2 semanas atrás

    Santo Amaro, Bahia, Brasil beBeeClinicalResearch Tempo inteiro

    The Role of a Clinical Research Medical AdvisorThis is an exciting opportunity to work with our team, leading clinical research and development initiatives that make a meaningful impact in the lives of patients.About the JobWe are seeking an experienced Clinical Research Medical Advisor to join our team. As a key member of our organization, you will be...

  • Senior Clinical Research Operations Manager

    Há 3 dias

    Buenos Aires, Espírito Santo, Brazil beBeeClinicalResearch Tempo inteiro R$90.000 - R$150.000

    Job Title:Clinical Research Project ManagerJob Summary:We are seeking a seasoned Clinical Research Project Manager to lead the operational management and oversight of clinical investigative sites and clinical monitoring deliverables for our clinical trials. The successful candidate will have prior experience in managing clinical monitoring activities,...

  • Clinical Project Manager

    Há 6 dias

    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...

  • Senior Clinical Trial Manager

    Há 7 dias

    Santo Amaro, Bahia, Brasil beBeeClinical Tempo inteiro R$90.000 - R$120.000

    Job SummaryThe role involves planning, executing, and interpreting clinical trials research, data collection activities, and clinical operations. Collaboration with investigational sites, clinical consultants, Contract Research Organizations & vendors is required. This position directs activities to execute and deliver assigned studies, ensuring adherence to...

  • Clinical Research Associate Ii

    2 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...

  • Clinical Research Associate II

    1 semana atrás

    Buenos Aires, Espírito Santo, Brazil CTI Clinical Trial and Consulting Services Tempo inteiro

    OverviewClinical Research Associate II - CRA II role at CTI Clinical Trial and Consulting Services. CTI is a global, privately held, full-service clinical contract research organization (CRO) focused on advancing treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug...

  • Clinical Project Manager

    2 semanas atrás

    Santo Amaro, Brasil Novartis Tempo inteiro

    **Summary**: LI-Onsite Location: São Paulo, Brazil Are you passionate about driving clinical research forward? Do you thrive in a dynamic, cross-functional environment? Join our team as a Clinical Project Manager (CPM) and play a key role in delivering impactful global drug development studies. **About the Role**: **About the Role**: As a Clinical Project...

  • Study Start-up Clinical Research Associate

    2 semanas atrás

    Santo Amaro, 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,...