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Regulatory Technician – CTIS Submissions | ICON plc | Spain Remote
Support CTIS data management, document uploads, and regulatory submissions for ICON plc’s clinical research operations. Coordinate submission activities and stakeholder follow-up to help advance medicines to patients.
Tavsif
- Manage activities in the Clinical Trials Information System (CTIS)
- Support submissions and related documents, including their assembly and dispatch
- Coordinate resources supporting regulatory submissions
- Identify and help mitigate CTIS data-management and document-upload risks through helpdesk support
- Work with internal and external stakeholders to resolve submission-related issues
- Maintain study-level account access for assigned CTIS projects
- Complete data entry and upload documents in CTIS
- Monitor CTIS activity and alert relevant stakeholders when action or follow-up is needed
- Prepare records of CTIS submissions, conclusions, decisions, and communications
- Conduct quality-control reviews in line with applicable procedures
- Keep submission work aligned with agreed timelines
- Complete project-specific training within the required timeframe
Talablar
- Advanced English proficiency is required for speaking, reading, and writing
- One to two years of relevant clinical research experience or familiarity with clinical terminology and documentation is preferred
- Able to work independently
- Regulatory submission and CTIS experience is advantageous but not required
- Must have the legal right to work in the country where the role is based
Imtiyozlar
- Base salary with performance-related incentives
- Health and wellbeing programmes, including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Structured training and career development pathways
- Reasonable accommodations throughout the recruitment process
- Inclusive and accessible workplace
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