Study Start up Specialist I, Biotech

1 dia atrás

São Paulo, São Paulo, Brasil IQVIA Tempo inteiro
Study Start up Specialist I, IQVIA Biotech

Join to apply for the Study Start up Specialist I, IQVIA Biotech role at IQVIA

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions

  • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
  • Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
  • Review and provide feedback to management on site performance metrics.
  • Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
  • Inform team members of completion of regulatory and contractual documents for individual sites.
  • Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
  • Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
  • Perform quality control of documents provided by sites.
  • May have direct contact with sponsors on specific initiatives.

Qualifications

  • 1 year clinical research experience. Equivalent combination of education, training and experience.
#J-18808-Ljbffr

  • Study Start-up Professional

    1 semana atrás

    São Paulo, São Paulo, Brasil beBeeIndustry Tempo inteiro R$87.445 - R$107.700

    Job OverviewWe are seeking a skilled professional to fill the role of Study Start-up Specialist. In this position, you will be responsible for overseeing Site Activation activities in accordance with local and international regulations, standard operating procedures (SOPs), project requirements, and contractual guidelines.Your primary duties will...

  • Senior Study Start up Specialist, Biotech

    Há 16 horas

    São Paulo, São Paulo, Brasil IQVIA Tempo inteiro

    Senior Study Start up Specialist, IQVIA Biotech Job Overview: Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. ...

  • Study Start up Specialist I

    2 semanas atrás

    São Paulo, São Paulo, Brasil IQVIA LLC Tempo inteiro

    Study Start up Specialist I Apply locations São Paulo, Brazil Time type Full time Posted on Posted Yesterday Job Requisition ID R1500196 Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project...

  • Study Start up Specialist I

    4 semanas atrás

    São Paulo, São Paulo, Brasil IQVIA LLC Tempo inteiro

    Study Start up Specialist IApply locationsSão Paulo, BrazilTime typeFull timePosted onPosted YesterdayJob Requisition IDR1500196Job OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and...

  • Clinical Start-Up

    Há 4 dias

    São Paulo, São Paulo, Brasil Fortrea Tempo inteiro US$70.000 - US$120.000 por ano

    Position SummaryThe Clinical Start-Up & Trial Lead (Start-Up + CTL) is responsible for the strategic planning, coordination, and oversight of clinical trial start-up activities as well as the ongoing execution of clinical studies. This hybrid role ensures operational excellence from site initiation through to study close-out, serving as the primary...

  • Clinical Start-Up

    1 dia atrás

    São Paulo, São Paulo, Brasil Fortrea Tempo inteiro

    OverviewJoin to apply for the Clinical Start-Up & Trial Lead role at Fortrea.The Clinical Start-Up & Trial Lead (Start-Up + CTL) is responsible for the strategic planning, coordination, and oversight of clinical trial start-up activities as well as the ongoing execution of clinical studies. This hybrid role ensures operational excellence from site initiation...

  • Clinical Start-Up

    Há 19 horas

    São Paulo, São Paulo, Brasil Fortrea Tempo inteiro

    Overview Join to apply for the Clinical Start-Up & Trial Lead role at Fortrea . The Clinical Start-Up & Trial Lead (Start-Up + CTL) is responsible for the strategic planning, coordination, and oversight of clinical trial start-up activities as well as the ongoing execution of clinical studies. This hybrid role ensures operational excellence from site...

  • Study Start Up Manager

    Há 7 horas

    São Paulo, São Paulo, Brasil Medpace Tempo inteiro

    OverviewOur LATAM clinical trial activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Study Start Up team in Sao Paulo This position plays a key role in the study start up process at Medpace.ResponsibilitiesEfficiently manage and successfully execute all aspects of global...

  • Study Start Up Manager

    Há 2 dias

    São Paulo, São Paulo, Brasil Medpace Tempo inteiro US$70.000 - US$120.000 por ano

    Our LATAM clinical trial activities are growing rapidly, and we are currently seeking a full-time, office-basedRegulatory Submissions Managerto join our Study Start Up team in Sao Paulo This position plays a key role in the study start up process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your...

  • Study Start Up Manager

    Há 7 horas

    São Paulo, São Paulo, Brasil Medpace Tempo inteiro

    OverviewOur LATAM clinical trial activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Study Start Up team in Sao Paulo This position plays a key role in the study start up process at Medpace. If you want an exciting career where you use your previous expertise and can develop and...