Senior Study Start Up Associate

hace 2 días

Santiago de Chile ICON Plc A tiempo completo

Study Start Up Associate II - Chile - Homebased

ICON 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 development

What you will be doing:

- Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
- Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
- Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
- Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.

Your profile:

- Bachelor's degree in life sciences or a related field.
- 3 to 6 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
- Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
- Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Mentor and train other personnel in the Study Start Up department processes and activities, as assigned.
- Efficiently Drive Study Initiation: Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities.
- Deputize for country Study Start Up Manager and/or other SSU staff as appropriate.
- Empower Success through Specialized SSU Expertise: Provide expertise to Study Start Up team leads and project teams, providing valuable insights to drive success.
- Ensuring Regulatory Compliance: Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines.
- Safeguarding Patient Welfare: Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent.

LI-DT2

LI-Remote

What ICON can offer you:

- Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
- In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
- Our benefits examples include:
- Various annual leave entitlements- A range of health insurance offerings to suit you and your family’s needs.- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.- Life assurance- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our

careers site

to read more about the benefits ICON offers.

  • Study Start Up Associate Ii

    hace 3 días

    Santiago de Chile 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 fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...

  • Study Start Up Associate I

    hace 2 días

    Santiago de Chile Icon plc A tiempo completo

    Study Start Up Associate I - Chile - Home or office based ICON 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 development What you will bring: - Responsible for...

  • Associate Study Start-up Manager, Chile

    hace 3 días

    Santiago de Chile 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...

  • Associate Project Manager, Start-up

    hace 3 días

    Santiago de Chile Labcorp A tiempo completo

    GENERAL - Lead start-up team during study start-up phase liaising directly with Lead SUPM or Project Lead, core team members and the client, as applicable. - Serve as client’s contact for start-up and maintenance processes and oversight. Responsible for establishing a strong working relationship with client’s project teams. - Monitor and control start up...

  • Study Start-up Specialist I/ii, Chile

    hace 3 días

    Santiago de Chile Novasyte A tiempo completo

    Help create a healthier world: START RIGHT HERE AT IQVIA. Proficiency in English, both verbally and written are necessary. Please submit resume in English. 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...

  • Study Start-up Specialist I/ii, Chile

    hace 2 días

    Santiago de Chile Novasyte A tiempo completo

    Help create a healthier world: START RIGHT HERE AT IQVIA. Proficiency in English, both verbally and written are necessary. Please submit resume in English. 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...

  • Senior Clinical Research Associate

    hace 2 días

    Santiago de Chile CTI Clinical Trial Services, Inc A tiempo completo

    **Senior Clinical Research Associate** (Level dependent on experience)** **Please submit your CV in English for Quickest Review Process!** Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can...

  • Study Start Up Manager, Biotech

    hace 1 día

    Santiago, Metropolitana, Chile IQVIA A tiempo completo

    IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.Job OverviewDirect and manage the...

  • Study Start Up Manager, Biotech

    hace 41 minutos

    Santiago, Metropolitana, Chile IQVIA A tiempo completo

    Santiago, Chile | Full time | Home-based | R1504165Job available in additional locationsIQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that...

  • Clinical Research Associate

    hace 1 semana

    Santiago de Chile MSD A tiempo completo

    **Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and...