Fsp - Regulatory and Start Up Specialist Mex

hace 6 días

Desde casa, México IQVIA A tiempo completo

We 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 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**- Bachelor Degree in life sciences.- +3 years of clinical research experience within regulatory area: submissions, knowledge of ICF, presentations to ethics committee, COFEPRIS.- Fluent English: written and oral communication skills

  • Regulatory & Start Up Specialist, Cfsp

    hace 2 semanas

    Desde casa, México IQVIA A tiempo completo

    We are looking for a **Regulatory & Start Up Specialist** to join our cFSP team in a Home Based role!**Location**: Argentina & México**What You´ll Do**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...

  • Regulatory & Start Up Specialist 2, Cfsp

    hace 1 semana

    Desde casa, México IQVIA A tiempo completo

    **Regulatory & Start Up Specialist, c**FSP.** Location: Mexico - Full home based **Job Overview** This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a **point of contact for investigative sites and the study team members.** This includes supporting **site qualification**, site...

  • Regulatory & Start Up Specialist 2, Cfsp

    hace 1 semana

    Desde casa, México IQVIA A tiempo completo

    **Regulatory & Start Up Specialist, c**FSP.**Location: Mexico - Full home based**Job Overview**This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a **point of contact for investigative sites and the study team members.** This includes supporting **site qualification**, site level...

  • Regulatory & Start Up Specialist 2, Cfsp

    hace 3 días

    Desde casa, México IQVIA A tiempo completo

    **Regulatory & Start Up Specialist, c**FSP - US/CAN Support** Location: Mexico - Full home based **Job Overview** This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a **point of contact for investigative sites and the study team members.** This includes supporting **site...

  • Regulatory & Start Up Specialist I - Central Hub

    hace 4 semanas

    Desde casa, México IQVIA A tiempo completo

    **Job Overview**Perform country-level tasks related to Site Activation (SA) activities at a global scope, ensuring compliance with local and international regulations, standard operating procedures (SOPs), project requirements, and budgetary guidelines. This role may also involve maintenance activities.**Essential Functions**:- Serve as Single Point of...

  • Site Activation Specialist

    hace 4 semanas

    Desde casa, México IQVIA A tiempo completo

    **Site Activation Specialist for External Commerce (ComEx) - Homebased****Essential Functions**- Responsible for importations and exportation activities in Mexico for our FSP model- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.- Perform start up and site activation...

  • Regulatory Specialist 2, Fsp

    hace 4 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,...

  • Regulatory Specialist 2, Fsp

    hace 1 día

    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,...

  • Regulatory and Start Up Clinical Research Spec

    hace 6 días

    Desde casa, México IQVIA A tiempo completo

    Job 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 contractual/budgetary guidelines. May also include maintenance activities.Essential Functions- Under general supervision, serve as...

  • Study Start-up Specialist/manager

    hace 6 días

    Desde casa, México IQVIA A tiempo completo

    **Unleash Your Potential**: **It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward.**: **Join IQVIA and...