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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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
Job details are sourced from the employer's original posting.
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