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ICON plc — денсаулық сақтау және фармацевтика салаларына қызмет көрсететін жаһандық келісімшарттық зерттеу ұйымы. Компанияның жұмысы бастапқы зерттеулерден бастап нарыққа шығарудан кейінгі қызметтерге дейін дәрі-дәрмек әзірлеуді қолдайтын клиникалық, консультациялық және коммерциялық қызметтерді қамтиды. ICON plc орталықтандырылмаған клиникалық зерттеулер, жүрек қауіпсіздігі, ерте клиникалық зертханалар, медициналық бейнелеу, реттеуші ақпарат және нақты өмір деректері сияқты шешімдер ұсынады. Сондай-ақ компания жүрек-қантамыр аурулары, онкология, ішкі аурулар, жасушалық және гендік терапиялар, биосимилярлар сияқты бағыттарда терапиялық тәжірибесін қолданып, клиникалық бағдарламалардың ілгерілеуіне көмектесу үшін деректерді талдауды пациентке бағдарланған тәсілдермен ұштастырады.
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.
Сипаттама
- 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
Талаптар
- 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
Артықшылықтар
- 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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