Site Specialist II (Regulatory Submissions)

ICON; Buenos Aires; Híbrido; ARS 63.383.000 - 93.565.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Life assurance

Retirement planning offerings

Global Employee Assistance Programme (

LifeWorks

Descripción de la vacante

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. We are currently seeking a Site Specialist II (Study Start Up Associate II) to join our diverse and dynamic team.

As a Site Specialist I at ICON, you will support investigator sites with key administrative and operational activities to help ensure clinical trials run smoothly, efficiently, and in compliance with applicable regulations.

Formación

• Bachelor’s degree in Life Sciences or equivalent.
• +2 years’ experience or understanding of clinical study start up requirements.
• Knowledge of local and/or international regulatory processes including submissions to regulatory authorities and ethics committees.
• Ability to read and understand clinical protocols, regulatory documents, and study-specific processes.
• Strong attention to detail and organizational skills.
• Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.
• Excellent communication skills in English and Spanish.

Responsabilidades

• Collect, review, organize and assemble start-up and maintenance submission packages to EC/IRB, Local EC/IRB and authorities.
• Support assembly of documents for the Critical Document Package (CDP) and site activation.
• Coordinate translations for start-up documentation.
• Progress data entry of documents and site activation tasks into tracking systems.
• Participate in study review meetings and provide updates on site progress.
• Forecast Site Activation plans and keep records in ICON’s systems.
• Ensure TMF documents are complete and QC’d before filing.
• Attend study team meetings as required.

Conocimientos

Attention to detail

Multitasking

Independent worker

Regulatory knowledge

Bilingual English/Spanish

Educación

Bachelor's degree in Life Sciences

Herramientas

TMF systems

Document tracking tools

Descripción del empleo

Site Specialist II

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

We are currently seeking a Site Specialist II (Study Start Up Associate II) to join our diverse and dynamic team. As a Site Specialist I at ICON, you will support investigator sites with key administrative and operational activities to help ensure clinical trials run smoothly, efficiently, and in compliance with applicable regulations.

Responsibilities:

• Collect, review, organize and assemble initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.

• Support collection and assembling of all documents needed in the Critical Document Package (CDP) and/or those required for site activation, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable requirements and ICH/GCP guidelines.

• Support coordination of all necessary translations required for any start-up documentation.

• Perform timely and accurate progress data entry of all documents collected from sites and of the relevant study site activation activities into the appropriate tracking systems and tools.

• Participate to internal study review meetings with study teams to provide updates on site progress in document collection and on the executed site activation tasks.

• Accurately forecast Site Activation plans and ensure that they are reflected accurately in ICON’s systems and proactively follow through for achievement to plan.

• Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF.

• Attend study team meetings as required

What you need to succeed in the role:

• Bachelor’s Degree preferably in Life Sciences

• +2 years’ experience or understanding of clinical study start up requirements and activities.

• Knowledge of local and/or international regulatory processes, including submissions to regulatory authorities and ethics committees.

• Ability to read and understand clinical protocols, regulatory documents, and study-specific processes.

• Strong attention to detail and organizational skills.

• Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.

• Excellent communication skills both in English and Spanish

#LI-FP1

#LI-Hybrid

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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here