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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.
Job Responsibility:
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
Requirements:
Mandatory advanced English (speak, read, write)
Ideally 1-2 years relevant experience within clinical research or knowledge of clinical terminology and documentation
Ability to work independently
Experience with regulatory submissions and CTIS is a differential but not mandatory
What we offer:
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