Clinical Research Associate Ii

1 dia 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 site performance management (recruitment & quality) and early identification of real site needs and issues as the single best point of contact (internally & externally) for all sites. (from issue management to risk identification).
**About the Role**:
**Major accountabilities**:
- Conducts continuous site monitoring activities (onsite and remote) and manages assigned study sites, conducting phase I-IV protocols. Implements site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including Health Authorities, IRB/EC, data privacy requirements, global and local processes as applicable. Documentation according to GDP and Novartis standards.
- Performs Site Initiation Visit and Site Closeout activities per SOPs and applicable regulations.
- Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset.
- Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at site.
- Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study team
- Proactively collaborates with the SSO Clinical Project Manager (CPM) and CRA Manager as well as MSL, CRMA and medical advisor to ensure optimal recruitment, site development and data quality.
- Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines.
- Ensures the site Investigator Folder is up to date. Responsible for collecting essential documents from site and accountable to keep sTMF(s) up to date.
**Key performance indicators**:
- Next level of site collaboration measured by patient density at site, achievements of commitments and targets and deliver customer satisfaction results.
- Meets study milestones.
- Ensures the delivery of high-quality data according to agreed timelines with adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements.
- Quality and timeliness of updating the Novartis systems, monitoring reports, and communication efforts as defined by global KPIs and KQIs
**Minimum Requirements**:
**Work Experience**:
- Degree in scientific or healthcare discipline
- Field monitoring experience
- Operations Management and Execution.
- At least 2 years pharmaceutical industry experience.
- Collaborating across boundaries.
**Skills**:
- Clinical Monitoring/Research/Trials.
- Fast change adaptability.
- Collaboration.
- Data Integrity.
- Decision Making Skills.
- Ability to travel.
- Good communication skills
- Ability to manage sites independently
- Time management and organization capabilities
**Languages**:
- English (Written and Spoken).
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 Specialist

    Há 22 horas

    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...

  • Clinical Research Manager I

    1 semana 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...

  • Study Start-up Clinical Research Associate

    4 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,...

  • Clinical Research Medical Advisor

    3 semanas atrás

    Santo Amaro, Bahia, Brasil Novartis Farmacéutica Tempo inteiro

    About the RoleKey ResponsibilitiesValidate 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...

  • Clinical Research Medical Advisor

    1 dia 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...

  • Clinical Trial Associate

    1 semana 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...

  • Sr. Field Medical Lead

    Há 2 horas

    Santo Amaro, Bahia, Brasil Novartis Tempo inteiro

    **Summary**:Lead scientific engagement with their Medical Experts.Implement clinical and educational strategies and respond to unsolicited medical enquirers.**About the Role**:Work Model: on-siteLocation: Rio de Janeiro (RJ)Travel Sector: Rio de Janeiro and Parana states**Major accountabilities**:- Engage with Medical Experts to educate on medical/scientific...

  • Clinical Access Strategist

    2 semanas atrás

    Santo Amaro, Bahia, Brasil beBeeMarketAccess Tempo inteiro R$124.250 - R$148.950

    Job Title:Access and Healthcare Lead">Job Description:">As a key member of our team, you will be responsible for developing and implementing innovative access strategies for our brands.You will work closely with cross-functional teams to co-create the brand strategy and lead an innovative access strategy for brands in collaboration with PAGs, Medical,...

  • Sr Medical Manager for Oncology

    1 semana 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...

  • Rwe Study

    1 semana atrás

    Santo Amaro, Bahia, 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...