CTIS Regulatory Technician - Submissions & Data Management

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

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