Fsp - Sr. Regulatory And Start Up Specialist In Brazil
1 semana atrás
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 needed • Bachelor's degree in Health Sciences • +3 years of experience in the Site Activation/Regulatory department in: ICF customization Preparation and submission of studies in startups to local and central ethics committees Collection of essential documents from the sites Preparation of initial DDCM
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São Paulo, Brasil IQVIA LLC Tempo inteiroFSP - Sr. Regulatory and Start Up Specialist in Brazil page is loaded## FSP - Sr. Regulatory and Start Up Specialist in Brazillocations: São Paulo, Braziltime type: Full timeposted on: Posted Todayjob requisition id: R Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international...
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FSP - Sr. Regulatory and Start Up Specialist in Brazil
1 semana atrás
São Paulo, São Paulo, Brasil IQVIA Tempo inteiroSao Paulo, Brazil | Full time | Home-based | R1518042Perform 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...
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São Paulo, Brasil BZL IQVIA RDS Brasil Ltda Tempo inteiroPerform 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...
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São Paulo, Brasil IQVIA Tempo inteiroPerform 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...
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Fsp - Regulatory & Start Up Specialist
2 semanas atrás
São Paulo, Brasil IQVIA Tempo inteiroUnder moderate supervision, the **Site Activation Specialist**executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level.Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites...
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FSP - Regulatory and Start-up Specialist
1 semana atrás
São Paulo, São Paulo, Brasil IQVIA Tempo inteiroUnder moderate supervision, the Site Activation Specialist executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level.Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and...
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FSP - Regulatory and Start-up Specialist
2 semanas atrás
São Paulo, São Paulo, Brasil IQVIA Tempo inteiroUnder moderate supervision, the Site Activation Specialist executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level.Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites...
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FSP - Sr. Regulatory and Start Up Specialist in Brazil
1 semana atrás
São Paulo, São Paulo, Brasil IQVIA Tempo inteiroPerform 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...
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Fsp - Regulatory And Start-Up Specialist
1 semana atrás
São Paulo, Brasil IQVIA Tempo inteiroRegulatory Officer - Agrochemical Sector (International Scope)📍 Location: Netherlands (Relocation Support & Visa Sponsorship Provided)Are you an experienced regulatory professional with a passion for plant science, compliance, and international markets? A global player in the agrochemical and crop protection sector, headquartered in the Netherlands, is...
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Line Manager Regulatory and Start Up
1 semana atrás
São Paulo, Brasil IQVIA LLC Tempo inteiroLine Manager Regulatory and Start Up page is loaded## Line Manager Regulatory and Start Uplocations: São Paulo, Braziltime type: Full timeposted on: Posted Yesterdayjob requisition id: R **Job Overview** Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs,...
