Regulatory Technician

ICON Clinical Research; Barcelona; On-site; EUR 32,000 - 52,000; Full time

Job summary

ICON is a global healthcare intelligence and clinical research organisation focused on bringing new medicines to patients faster. As a Regulatory Technician, you will work with the Clinical Trials Information System (CTIS) and support submissions and related documents, coordinating resources for submissions and ensuring compliance across projects.

You will proactively identify risks via CTIS helpdesks, manage study-level CTIS access, and perform data entry and document uploads while maintaining

Qualifications

• Mandatory advanced English (speak, read, write).
• 1–2 years relevant experience within clinical research or knowledge of clinical terminology and documentation.

Responsibilities

• Proactively identify and mitigate risks through CTIS helpdesks regarding data/document management and upload to CTIS and liaise with internal/external stakeholders to resolve
• Actively maintain applicable study-level account access for CTIS to maintain compliance and confidentiality
• Collaborate with key stakeholders to manage and perform data entry and document upload
• Monitor CTIS notifying applicable stakeholders of activities for their action and subsequent follow up
• Create files documenting submissions completed through CTIS, conclusions, decisions and any other communication provided via CTIS
• Perform Quality Control review in accordance with applicable process
• Maintain agreed timelines
• Ensure project-specific training is completed on time, as applicable

Skills

Advanced English

CTIS knowledge

Independent worker

Tools

CTIS

Job description

Regulatory Technician

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.

As a Regulatory Technician you will work with the Clinical Trials Information System (CTIS), and will also provide support for submissions and other documents by performing necessary tasks including assembly, dispatch among others and coordinating resources for submissions,

Responsibilities

• Proactively identify and mitigate risks through CTIS helpdesks regarding data/document management and upload to CTIS and liaise with internal/external stakeholders to resolve
• Actively maintain applicable study-level account access for assigned projects for CTIS to maintain compliance and confidentiality
• Collaborate with key stakeholders to manage and perform data entry and document upload
• Monitor CTIS notifying applicable stakeholders of activities for their action and subsequent follow up
• Create files documenting submissions completed through CTIS, conclusions, decisions and any other communication provided via CTIS
• Perform Quality Control review in accordance with applicable process
• Maintain agreed timelines
• Ensure project-specific training is completed on time, as applicable

To succeed you will need

• Mandatory advanced English (speak, read, write)
• Ideally you will have 1-2 years relevant experience within clinical research or have knowledge of clinical terminology and documentation
• Ability to work independently
• Experience with regulatory submissions and CTIS is a differential but not mandatory

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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 (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable-accommodations)