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Country Approval Asociate
hace 3 semanas
Trial Activation Approval Specialist I
Essential Functions and Other Job Information: Essential Functions - Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. - Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy. - Coordinates, under guidance, with internal functional departments to ensure Consulta de detalles: Petición de puesto: R-01203605 Trial Activation Approval Specialist I 11:20 04/09/2023 Página 2 de 3 various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation. - Achieves PPD’s target cycle times for site. - May have contact with investigators for submission related activities. - May act as a key-contact at country level for either Ethical or Regulatory submission-related activities. - Works with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. - Assists in developing country specific Patient Information Sheet/Informed Consent form documents. - Assists with grant budgets(s) and payment schedules negotiations with sites. - Enters and maintains trial status information relating to SIA activities onto PPD, or client (where contracted) tracking databases in an accurate and timely manner - Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. - Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
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Country Approval Asociate
hace 2 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoTrial Activation Approval Specialist I Essential Functions and Other Job Information: Essential Functions - Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. - Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy. -...
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Country Approval Associate
hace 4 semanas
Desde casa, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Other **Environmental Conditions** Office Essential Functions - Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. - Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy. - Coordinates, under...
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Country Approval Associate
hace 5 días
Desde casa, México Thermo Fisher Scientific A tiempo completoWork ScheduleOtherEnvironmental ConditionsOfficeEssential Functions Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy. Coordinates, under guidance, with internal...
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Trial Activation Approval Specialist I
hace 2 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**Job Description**: Trial Activation Approval Specialist I Essential Functions and Other Job Information: Essential Functions - Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. - Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global...
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Trial Activation Approval Specialist I
hace 5 días
Desde casa, México Thermo Fisher Scientific A tiempo completoJob Description:Trial Activation Approval Specialist IEssential Functions and Other Job Information:EssentialFunctions Prepares, reviews and coordinates, under guidance and local EC submissions inalignment with global submission strategy. Supports preparation, under guidance, of local MoH submissions, as applicable inalignment with global submission...
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Fsp - Site Managment Coordinator
hace 2 meses
Desde casa, México IQVIA A tiempo completoJob Overview Under general supervision, perform tasks at a country level associated with site activation 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...
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Site Activation Specialist
hace 1 semana
Desde casa, México IQVIA A tiempo completo**Job Overview** Under moderate supervision, 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 sponsors;...
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Site Activation Specialist
hace 3 semanas
Desde casa, México IQVIA A tiempo completoJob Overview Under moderate supervision, 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 sponsors;...
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Fsp - Site Managment Coordinator
hace 6 días
Desde casa, México IQVIA A tiempo completoJob OverviewUnder general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or internationalregulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.Essential Functions Under general...
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Site Contracts Activation Specialist
hace 2 semanas
Desde casa, México IQVIA A tiempo completoJob Overview Under moderate supervision, 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 sponsors;...
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Site Activation Coordinator
hace 2 meses
Desde casa, México IQVIA A tiempo completoJob Overview Under general supervision, perform tasks at a country level associated with site activation 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...
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Local Start Up Specialist
hace 4 semanas
Desde casa, México Allucent A tiempo completoThese customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in...
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Site Activation Specialist
hace 5 días
Desde casa, México IQVIA A tiempo completoJob OverviewUnder moderate supervision, 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 sponsors; maintains,...
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Regulatory and Start Up Clinical Research Spec
hace 3 semanas
Desde casa, México IQVIA A tiempo completoJob 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...
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Regulatory Specialist 2, Fsp
hace 2 semanas
Desde casa, México IQVIA A tiempo completo**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,...
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Digital Marketing and Content Coordinator
hace 7 días
Desde casa, México Viatris A tiempo completo3842 Viatris Healthcare México S. de R.L. de C.V At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality...
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Fsp - Regulatory and Start Up Specialist Mex
hace 3 semanas
Desde casa, México IQVIA A tiempo completoWe are looking for a **Regulatory & Start Up Specialist** to join our FSP team in a Home Based role! **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...
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Site Monitor
hace 2 semanas
Desde casa, México Parexel A tiempo completoMexico, Remote **Job ID** R0000020557 **Category** Clinical Trials **ABOUT THIS ROLE**: Parexel FSP is hiring a Site Monitor to support the Mexico region. The Site Monitor will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level.Monitoring will be conducted in line with the Study...
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Assoc Site Start-up Specialist
hace 2 meses
Desde casa, México IQVIA A tiempo completoJob 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...
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Site Activation Partner
hace 3 semanas
Desde casa, México Parexel A tiempo completoResponsible for supporting the SRPs and investigator for Targeted Sites: **Clinical Trial Site Activation & Conduct** - Assist with study site activation activities to ensure timely site activation - Register investigator sites in Client registries, as required - Support and/or coordinate central Investigator Review Board (IRB) submissions when needed. -...