Study Start-up Manager, Mexico

hace 1 semana

Ciudad de México Novasyte 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 see where your skills can take you.

BASIC FUNCTIONS:
Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) during start-up. Work with both internal and external teams to assure good communication, regarding documentation processing. Assure documents maintained are following International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients. A SSUS II may be assigned to one or more start-up projects, and typically is able to work independently on a project with mínimal supervision.

Responsible for providing customer-focused leadership in the execution of operational strategy and management of start-up activities for projects or programs. This includes but not limited to the overall management and oversight of the following processes: site feasibility, regulatory approvals, and site contracts. May be assigned to manage the site start-up activities for a country, region, or global trial.

Responsible for maintaining internal tracking for study site status from initial site contact through site initiation and maintains clear client and internal team communication and documentation. This position works directly with Clinical Monitoring, Project Management and Clinical Trial Managers in setting priorities and expectations for study start-up.

MINIMUM RECRUITMENT STANDARDS:
- BS /BA/BSc or equivalent in a health-related field plus 7 years of related clinical trials experience- within the total years of experience, at least 2-3 years of project lead experience is required-
- Equivalent combination of education, training and experience

LI-RW1

LI-Remote

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

  • Study Start Up Manager

    hace 2 semanas

    Ciudad de México, Ciudad de México Medpace, Inc. A tiempo completo

    Our 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 Mexico City 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...

  • Study Start Up Manager

    hace 2 semanas

    Ciudad de México, Ciudad de México Medpace A tiempo completo

    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 Mexico City 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

    hace 4 semanas

    Ciudad de México ICON A tiempo completo

    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: Accountability & Delivery,...

  • Study Start Up Associate I

    hace 6 días

    Ciudad de México ICON Plc A tiempo completo

    Study Start Up Associate I - Hybrid - Mexico CityICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Study Start Up Associate...

  • Study Start Up Associate I

    hace 6 días

    Ciudad de México ICON Plc A tiempo completo

    Study Start Up Associate IICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Study Start Up Associate I to join our diverse...

  • Study Start Up Associate I

    hace 4 semanas

    Ciudad de México ICON plc A tiempo completo

    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 organization: Accountability & Delivery,...

  • Study Start Up Associate II

    hace 2 semanas

    Ciudad de México, Ciudad de México ICON plc A tiempo completo

    Regulatory Exp., Home Based - MxICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Study Start Up Associate II to join our...

  • Clinical Start-up

    hace 2 semanas

    Ciudad de México Fortrea A tiempo completo

    **Position Summary**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 through to study close-out, serving as the primary...

  • Clinical Research Study Start-up Project Manager

    hace 1 semana

    Ciudad de México Medpace, Inc. A tiempo completo

    Job Summary: Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Study Start-Up Manager (Regulatory Submissions Manager) to support our growing Study Start-Up/Regulatory Submissions team at Medpace! This position plays a key role in the clinical trial management process at Medpace. If you want an...

  • Study Start Up Associate I

    hace 2 semanas

    Ciudad de México Icon plc A tiempo completo

    Study Start Up Associate I (Regulatory Submissions) Mexico City - Hybrid SchemeICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently...