Description
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
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.
Responsibilities:
- 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.
Your 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 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.
Rewards & 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.