Evidence Generation Specialist

2 semanas atrás

Sao Paulo, Brasil AstraZeneca Tempo inteiro

AstraZeneca is one of the most fascinating biopharmaceutical companies in the world. From researchers to sales people, from lab technicians to the legal department, we all have a mission to turn ideas into science, science into revolutionary medicines that save and extend patients’ lives and benefit society. Our portfolio is solid and our pipeline is innovative with a focus on biological medicines in the Cardio-Metabolic, Respiratory and Oncology areas.

The Project Manager is in charge to lead and manage projects that support the areas in strategic projects, as well as, responsible for all phases of a project including business justification, project initiation, planning, execution and closure in partnership with leader of each area.

**Responsibilities**:

- The Evidence Generation Specialist is responsible for leading execution activities of evidence generation studies in order to guarantee the quality and consistency of the project as a whole through activities that range from negotiating the study with vendors to completing the publication of the studies.
- Contributes to the monitoring, review, and closure of operational activities related to Externally Sponsored Research (ESR) and the Early Access Program, when necessary.
- Monitors compliance by team members and third parties, as well as positively enforces the Code of Conduct and all relevant legal and regulatory requirements of AstraZeneca Policies and Standards.
- Activities developed under the supervision of the department manager.
- Lead the identification and contracting of external suppliers.
- Lead the high risk study execution since the study design concept, study execution, including governance process, vendor management until the study publication.
- Lead and review the set-up of the Trial Master File (TMF/eTMF) including tracking of documents. Maintain and close the TMF/eTMF ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance.
- Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, Investigator meetings. Liaise with internal and external participants and/or vendors.
- Lead all project payments flows according to contract agreements and project milestones.
- Responsibility to contribute with the GxP areas to ensure the legal and regulatory requirements of evidence generation roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improvement; able to perform self-assessment according to internal and regulatory expectations, identify observations and improvement opportunity within the audit process.
- Lead study close out, study information and records archiving.

**_
Requirements:_**
- Bachelor’s degree in health area required
- Advanced spoken and written English
- GCP/ICH and Local regulation knowledge required
- Project management skills
- At least 3 years of previous experience from Clinical Operational Activities (regulatory, start up and / or clinical monitoring tasks)

  • Demand Generation Specialist

    1 dia atrás

    São Paulo, Brasil Metal Toad Tempo inteiro

    Metal Toad is an award-winning AWS Consulting Partner and AWS Managed Services provider company based in the USA. We help our customers with their cloud adoption by providing architecture, migration, optimization, machine learning, and even 24x7 support. We are a professional services firm providing services in software engineering and the cloud. We do...

  • Demand Generation Specialist

    4 semanas atrás

    São Paulo, Brasil Metal Toad Tempo inteiro

    Metal Toad is an award-winning AWS Consulting Partner and AWS Managed Services provider company based in the USA. We help our customers with their cloud adoption by providing architecture, migration, optimization, machine learning, and even 24x7 support. We are a professional services firm providing services in software engineering and the cloud. We do...

  • Compliance Specialist

    3 semanas atrás

    São Paulo, Brasil Velozient Tempo inteiro

    Compliance SpecialistWe are seeking a remote, full-time SOC 2 Compliance Specialist with expertise in SaaS environments and proficiency in using compliance management platforms (preferably Vanta). The ideal candidate will lead the client's SOC 2 compliance efforts, streamline evidence collection, ensure continuous monitoring, and support security and...

  • Lead Generation Specialist Us Travel Tech

    Há 3 dias

    São Paulo, São Paulo, Brasil Caderno Nacional Tempo inteiro US$104.000 - US$130.878 por ano

    Overview Segmento: Não Informado Atividades: They provide campgrounds and RV parks with a property management system and marketing services to help drive them more business. We are a small team and require a hands-on and hungry approach. Role Lead Generation Specialist who is passionate about Customer Relationship Management and has a startup...

  • Business Development Specialist

    1 semana atrás

    São Paulo, Brasil Amazon Tempo inteiro

    Business Development Senior Specialist Join the Worldwide Specialist Organization (WWSO) LATAM Data & AI team as a Business Development Specialist. Are you a customer-obsessed builder with a passion for helping customers achieve their full potential? Do you have the business savvy, analytics background, and sales skills necessary to help position AWS as the...

  • Growth & Lead Generation Specialist

    1 minuto atrás

    São Paulo, Brasil Coface Tempo inteiro

    Overview At Coface, we make trade happen everyday. Our 5,200 experts representing 80+ nationalities in 58 countries are united by a shared purpose: helping companies navigate through uncertainty by empowering them to make the right decisions and trade smarter in a complex world. With nearly 80 years of global experience, we offer companies a full range of...

  • Digital Workplace Analytics Specialist

    1 dia atrás

    Sao Paulo, Brasil Unilever Tempo inteiro

    **Unilever is hiring a Digital Workplace Analytics Specialist** **for São Paulo/SP.** Unilever is the place where you can bring your purpose to life with the work you do - creating a better business and a better world. We are looking for talent who would like to join us on this exciting journey. Our **Technology** team is embarking on an incredible...

  • Digital Workplace Analytics Specialist

    4 semanas atrás

    Sao Paulo, Brasil Unilever Tempo inteiro

    **Unilever is hiring a Digital Workplace Analytics Specialist****for São Paulo/SP.**Unilever is the place where you can bring your purpose to life with the work you do - creating a better business and a better world. We are looking for talent who would like to join us on this exciting journey.Our **Technology** team is embarking on an incredible journey, we...

  • Marketing Automation Specialist

    1 semana atrás

    Sao Paulo, Brasil 3M Tempo inteiro

    **Marketing Automation Specialist, Latin America** **Collaborate with innovative 3Mers around the world** As Marketing Automation Specialist you will play a key role for the Transportation and Electronics Business Group, assuring that campaigns and marketing automation projects are delivered to 3M customers in Latin America. In this role you will blend...

  • EMS Specialist

    1 semana atrás

    São Paulo, Brasil Tata Consultancy Services Tempo inteiro

    Come to one of the biggest IT Services companies in the world!! Here you can transform your career!Why to join TCS? Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools, contributing to...