Brazil - Senior Clinical Scientist Consultant

Há 4 dias

Brasília, Distrito Federal, Brasil ClinChoice Tempo inteiro R$120.000 - R$250.000 por ano

Senior Clinical Scientist I
(Clinical Research/Clin Ops)

Description of Services

  • May lead or support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol.
  • As lead, will be responsible for the following:
  • Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites)
  • Responsible for trial design and endpoint development in collaboration with CD
  • Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports
  • Sets up/supports SAC, DMC, adjudication committees
  • Protocols/amendments – collaborates with medical writer, participates in governance committee review
  • Authors protocol clarification letters
  • Contributor to study specific documents (e.g., SMP)
  • Reviews/updates informed consent
  • Provides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs)
  • Monitors data issues requiring clinical input
  • Monitors central lab reports and other external data for safety and critical values
  • Prepares scientific slides, attends and presents protocol information at Investigator Meeting
  • Scientific lead on Clinical Trial Team (CTT)
  • Reviews specs, initiates allocation (randomization) request form and approval schedule in allocation schedule generation system
  • Coordinates planning of lab, bio specimens and imaging specifications
  • Co- authors newsletters with SM
  • Participates in Database lock activities
  • Collaboratively plans CSRs, CTDs/WMAs with medical writing
  • Supports publications/presentations as needed
  • Reconciles and review all protocol deviation classifications in SPECTRUM
  • Assesses and prepares protocol deviation list for CSR
  • Collaborates with medical writing to develop trial results communication for investigators
  • Provides scientific assessment for Operational Reviews
  • Supports SM/MW activities as needed to achieve CTT deliverables.
  • Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO)
  • May act as mentor to other CSs

Minimum Years of Experience

  • Minimum 7 years for BS/BA or 5 years for MS/PhD pharmaceutical and/or clinical drug development (such as pharmaceutical/biopharma companies, hospital settings, research sites, clinical trial units, CRO, SMO) in the last 10 years required experience Minimum 2 years as a lead CS (phase I-IV clinical trials) with pharmaceutical/bio-tech/CRO company experience required (leads, monitors and supervises the tasks related to clinical trials) in the last 5 years.
  • TA-specific experience required for Oncology.TA specific experience preferred for IDV and GSM
  • Indication specific experience preferred
  • Experience reviewing and resolving study related data issues such as; issued queries, resolved queries, accurate review of medical records, identify any errors in data by performing data review that require further clarification with the study sites, etc. required
  • 2 years medical monitoring (proficient in reviewing patient data and resolving discrepancies in the following areas such as adverse events, trends of adverse events, end point management, labs) experience required
  • Demonstrated oral and written communication skills
  • Proficiency in Microsoft Office (Outlook, Word, Excel and PowerPoint) required. One Note experience preferred.
  • Motivate their team, handle and delegate responsibilities, listen to feedback and remain flexible.

Educational Requirements

  • Degree in Life Sciences
  • BS/BA/MS/PhD

  • Clinical Trial Psych Rater

    Há 4 dias

    Brasília, Distrito Federal, Brasil IQVIA Tempo inteiro R$104.000 - R$156.000 por ano

    Clinical Specialist Consultant -PortugueseSpeakingLocation: Remote/virtualHours: Estimated 10-16h/monthRole: Clinical SpecialistJob Description:The Clinical Specialist reviews scales administered by raters in a clinical trial to ensure that assessments are being conducted in a standardized manner to ensure data reliability. The quality of assessments is...

  • Data Scientist

    3 semanas atrás

    Brasília, Distrito Federal, Brasil Sigma Software Group Tempo inteiro

    OverviewJoin to apply for the Data Scientist role at Sigma Software Group.Streamline your career by joining our team as a Data Scientist We are looking for a dedicated professional with 3 years of commercial data science experience who is eager to contribute to data-related projects and take on a leadership role in our Data Competency Center. This role...

  • Executivo De Vendas

    3 semanas atrás

    Brasília, Distrito Federal, Brasil Finance Brazil Tempo inteiro

    Somos a Finance Brazil Uma empresa de inteligência financeira e tecnologia especializada em lucratividade e rentabilidade. Nossas soluções visam aumentar o valor da empresa por meio de alavancas de crescimento como Pricing, Ciclo de Caixa e Reestruturação Financeira. Tudo isso acompanhado de dashboards de Business Intelligence (BI) automatizados, que...

  • Data Scientist

    4 semanas atrás

    Brasília, Distrito Federal, Brasil Applaudo Tempo inteiro

    Data ScientistAbout YouYou are someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests and grow professionally.Job DescriptionYou are a data-driven professional passionate about turning complex data into actionable insights. You thrive on using advanced analytics, statistical...

  • Senior QA, Brazil

    3 semanas atrás

    Brasília, Distrito Federal, Brasil CI&T Software S.A. Tempo inteiro

    OverviewWe are tech transformation specialists, uniting human expertise with AI to create scalable tech solutions. With over 7,400 CI&Ters around the world, we've built partnerships with more than 1,000 clients during our 30 years of history. Artificial Intelligence is our reality.RoleAs a Senior QA Automation professional, you will be at the forefront of...

  • Data Engineer

    3 semanas atrás

    Brasília, Distrito Federal, Brasil AgileEngine Tempo inteiro

    Join to apply for the Data Engineer (Senior) ID40199 role at AgileEngineAgileEngine is an Inc. 5000 company that creates award-winning software for Fortune 500 brands and trailblazing startups across 17+ industries. We rank among the leaders in areas like application development and AI/ML, and our people-first culture has earned us multiple Best Place to...

  • Senior QA Automation, Brazil

    4 semanas atrás

    Brasília, Distrito Federal, Brasil CI&T Software S.A. Tempo inteiro

    OverviewWe are tech transformation specialists, uniting human expertise with AI to create scalable tech solutions.With over 7.400 CI&Ters around the world, we've built partnerships with more than 1,000 clients during our 30 years of history. Artificial Intelligence is our reality.ResponsibilitiesAs a Senior QA Automation, you will lead the strategy and...

  • Senior Game Designer

    3 semanas atrás

    Brasília, Distrito Federal, Brasil buscojobs Brasil Tempo inteiro

    We are seeking a Senior Game Designer with strong expertise in C#, Unity, VR, 3D, Game Design, and UI / UX to join our team in creating immersive and interactive virtual shopping experiences. The professional will lead the design and implementation of engaging VR environments, UI flows, and avatar interactions, ensuring smooth integration of 3D models and...

  • Senior Game Designer

    3 semanas atrás

    Brasília, Distrito Federal, Brasil buscojobs Brasil Tempo inteiro

    We are seeking a Senior Game Designer with strong expertise in C#, Unity, VR, 3D, Game Design, and UI / UX to join our team in creating immersive and interactive virtual shopping experiences. The professional will lead the design and implementation of engaging VR environments, UI flows, and avatar interactions, ensuring smooth integration of 3D models and...

  • Senior Data Developer PostgreSQL, Brazil

    3 semanas atrás

    Brasília, Distrito Federal, Brasil CI&T Software S.A. Tempo inteiro

    OverviewWe are tech transformation specialists, uniting human expertise with AI to create scalable tech solutions.With over 7.400 CI&Ters around the world, we've built partnerships with more than 1,000 clients during our 30 years of history. Artificial Intelligence is our reality.Job OverviewWe are seeking a Senior Data Developer with experience in database...