[Hiring] Senior Informed Consent Specialist @ICON plc

Role Description

As a Senior Informed Consent Specialist at ICON, you will lead the development and oversight of informed consent strategies and documents for complex, global clinical studies. You will act as a subject matter expert, ensuring participant-facing materials are ethical, compliant, and understandable.

What You Will Do:

• Take ownership of scientific operations deliverables, applying your expertise to complex challenges.
• Key responsibilities include:
• Leading the creation, review, and optimisation of global and country-specific informed consent forms for complex or high-risk studies.
• Advising study teams on informed consent strategies, including readability, cultural considerations, and local regulatory expectations.
• Overseeing translation, localisation, and version control processes to ensure consistency and traceability across regions.
• Interacting with sponsors, ethics committees, and regulatory authorities to address consent-related queries and negotiate wording as needed.
• Developing guidance, templates, and training materials to drive standardisation and best practices within the informed consent function.
• Mentoring junior informed consent specialists and contributing to continuous improvement initiatives.

Qualifications

• 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 strong focus on informed consent.
• In-depth knowledge of GCP, ethical principles, and global regulatory expectations for participant information and consent.
• Exceptional writing and editing skills, with the ability to produce clear, patient-friendly documents.
• Strong stakeholder management skills, with experience liaising with sponsors, IRBs/ECs, and cross-functional teams.
• Proven ability to manage multiple complex studies and deadlines with a high degree of accuracy and ownership.

Requirements

• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Benefits

• 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 wellbeing resources.
• Learning and development opportunities through structured training and career pathways.
• Benefits may vary depending on role and location.