Senior Informed Consent Specialist

About the role

ICON is a global healthcare intelligence and clinical research organisation. As a Senior Informed Consent Specialist, you will lead the development and oversight of informed consent strategies and documents for complex, global clinical studies, acting as a subject matter expert who ensures participant-facing materials are ethical, compliant and understandable.

Key responsibilities

• Take ownership of scientific operations deliverables and apply your expertise to complex challenges.
• Lead the creation, review and optimisation of global and country-specific informed consent forms for complex or high-risk studies.
• Advise study teams on informed consent strategies, including readability, cultural considerations and local regulatory expectations.
• Oversee translation, localisation and version control to ensure consistency and traceability across regions.
• Interact with sponsors, ethics committees and regulatory authorities to address consent-related queries and negotiate wording.
• Develop guidance, templates and training materials to drive standardisation and best practices.
• Mentor junior informed consent specialists and contribute to continuous improvement initiatives.

Required profile

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Extensive experience in clinical research, regulatory affairs, ethics or a related area with a strong focus on informed consent.
• In-depth knowledge of GCP, ethical principles and global regulatory expectations for participant information and consent.
• Proven ability to manage multiple complex studies and deadlines with accuracy and ownership.
• Legal right to work in the country where the role is based.

Required skills

• Exceptional writing and editing skills, able to produce clear, patient-friendly documents.
• Strong stakeholder management, with experience liaising with sponsors, IRBs/ECs and cross-functional teams.

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.