Regulatory Start-up/senior Site Activation

Há 7 dias


Lisboa, Portugal Novasyte Tempo inteiro

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; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines. With moderate oversight and supervision, perform tasks at a country/region 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
- With moderate oversight and supervision, werve a Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.
- Prepare site documents, reviewing for completeness and accuracy.
- Inform team members of completion of regulatory contractual. and other documents for individual sites.
- Distribute completed documents to sites and internal project team members.
- Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
- Review, track and follow up the progress, the approval and execution of required documents such as questionaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.

**Qualifications**:

- Bachelor's Degree Life sciences or a related field Req And
- Other 1 - 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience. Req
- With 3 years’ experience in a healthcare environment or equivalent combination of education, training and experience.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at



  • Lisboa, Portugal Novasyte Tempo inteiro

    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...


  • Lisboa, Lisboa, Portugal Novasyte Tempo inteiro

    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. Portuguese and English language proficiency.Essential...


  • Lisboa, Lisboa, Portugal Novasyte Tempo inteiro

    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. Fluent in both Portuguese and English. At least 1 years'...


  • Lisboa, Portugal Novasyte Tempo inteiro

    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. Fluent in both Portuguese and English. At least 1 years'...


  • Lisboa, Portugal Novasyte Tempo inteiro

    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. Portuguese and English language proficiency. Essential...


  • Lisboa, Portugal Novasyte Tempo inteiro

    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. Portuguese and English language proficiency. Essential...

  • Study Start Up Specialist

    3 semanas atrás


    Lisboa, Portugal TFS HealthScience Tempo inteiro

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. **Join Our Team as a** **Study Start Up Specialist - (home...

  • Sr Start-up Team Mgr

    2 meses atrás


    Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    PPD, a part of Thermo Fisher Scientific, is a leading global contract research organization focused on delivering life-changing therapies. Our mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people....

  • Sr Start-up Team Mgr

    1 semana atrás


    Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    PPD, a part of Thermo Fisher Scientific, is a leading global contract research organization focused on delivering life-changing therapies. Our mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it's you We know that meaningful results not only require the right approach, but also the right people. We...

  • Senior Start-up Specialist

    3 semanas atrás


    Lisboa, Portugal Labcorp Tempo inteiro

    Labcorp Drug Development As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired...

  • Start-up Specialist

    2 semanas atrás


    Lisboa, Portugal Fortrea - Organic Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Ctry Approval Spec

    3 semanas atrás


    Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health. Site and Patient Access is a global department working to provide rapid site activation and patient access to our clients. Our innovative approach is designed to help save our clients time and money while driving...


  • Lisboa, Portugal Medtronic Tempo inteiro

    The surgical robotics utilization team manages all aspects of system installation, start-up, customer training, account analysis, drive and optimize the robotic program. Placement of a HUGO surgical robot in the hospital requires full-time support for an account specific period to ensure successful integration into the hospital’s service lines. The...


  • Lisboa, Portugal Medtronic Tempo inteiro

    The surgical robotics utilization team manages all aspects of system installation, start-up, customer training, account analysis, drive and optimize the robotic program. Placement of a HUGO surgical robot in the hospital requires full-time support for an account specific period to ensure successful integration into the hospital’s service lines. The...

  • Manager, Study Start Up

    1 semana atrás


    Lisboa, Lisboa, Portugal ICON Tempo inteiro

    Manager, Study Start Up - Office Based - Madrid - SpainAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an...

  • Ctry Approval Spec

    3 semanas atrás


    Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...


  • Lisboa, Portugal ICON plc Tempo inteiro

    Study Start Up Associate At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation:...

  • Study Start Up Associate

    1 semana atrás


    Lisboa, Lisboa, Portugal ICON plc Tempo inteiro

    Study Start Up Associate - Spanish & Portuguese Speaker - Home BasedAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us...


  • Lisboa, Portugal Medtronic Tempo inteiro

    The surgical robotics utilization team manages all aspects of system installation, start-up, customer training, account analysis, drive and optimize the robotic program. Placement of a HUGO surgical robot in the hospital requires full-time support for an account specific period to ensure successful integration into the hospital’s service lines. The...

  • Study Start Up Associate Ii

    4 semanas atrás


    Lisboa, Portugal ICON Tempo inteiro

    Study Start Up Associate II - Barcelona At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an...