ICF Specialist
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Job description
About the role
ICON Strategic Solutions is hiring an ICF Specialist to work in a sponsor-dedicated model, fully embedded in a growing global biotechnology company. The role leads the development, review and oversight of informed consent documents for complex, global clinical trials. It is based in the UK, Poland, Spain or Bulgaria.
Key responsibilities
- Review and manage global, country-specific and site-level informed consent forms (ICFs), ensuring accuracy, consistency and protocol alignment.
- Assess ICF content for compliance with regulations, ethical standards and participant readability requirements.
- Apply plain language principles to create clear, patient-friendly informed consent documentation.
- Identify and resolve quality, compliance and content issues, escalating risks where appropriate.
- Contribute to improving ICF templates, processes and supporting documentation.
- Act as a key contact for ICF queries and coordinate reviews with internal stakeholders and external partners.
- Track review activities and support reporting on quality and performance metrics.
- Manage multiple priorities and urgent requests within study timelines.
- Provide additional support for R&D budget and contracts activities and other departmental initiatives.
Required profile
- Minimum of two years of experience working with informed consent forms.
- Preferred knowledge of ICH-GCP, FDA, EU CTR and other country regulations on informed consent.
- Excellent writing and editing skills, able to turn complex technical or legal information into clear, patient-friendly language.
- Self-starter who works independently, detail-oriented and comfortable with ambiguity.
- Ability to manage several tasks at once and meet deadlines.
- Legal right to work in the country where the role is based.
Required skills
- Proficiency with Microsoft Office.
- Good interpersonal skills.
What we offer
- Competitive base salary and 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 learning and development opportunities.
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Published 3 hours ago
Expires 1 month from now
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