CTIS Submissions Coordinator

KCR Placement; Barcelona; On-site; EUR 35,000 - 55,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance options

Retirement planning

Employee Assistance Programme (LifeWe

Life assurance

Country-specific benefits

Job summary

ICON is a global healthcare intelligence and clinical research organisation. We seek a Regulatory Technician to work with CTIS, assist with submissions and coordinate resources for filings. You will identify risks, maintain access controls, and liaise with stakeholders to ensure timely, compliant documentation.

Applicants should have advanced English and 1–2 years in clinical research or related terminology. Independent work ability and CTIS experience are beneficial but not mandatory.

Qualifications

• 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.

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

Skills

Advanced English

Clinical research experience

Independent work

CTIS knowledge

Job description

ICON is a global healthcare intelligence and clinical research organisation. We seek a Regulatory Technician to work with CTIS, assist with submissions and coordinate resources for filings. You will identify risks, maintain access controls, and liaise with stakeholders to ensure timely, compliant documentation.

Applicants should have advanced English and 1–2 years in clinical research or related terminology. Independent work ability and CTIS experience are beneficial but not mandatory.