ICON seeks a Senior Informed Consent Specialist in Madrid to lead the development and oversight of informed consent strategies and documents for complex, global clinical studies. The role involves ensuring participant-facing materials are ethical, compliant, and understandable while mentoring junior staff.
Responsibilities
- Lead creation, review, and optimisation of integral and country-specific informed consent forms
- Advise study teams on consent strategies including readability, cultural, and regulatory considerations
- Oversee translation, localisation, and version control processes across regions
- Interact with sponsors, ethics committees, and regulatory authorities on consent-related matters
- Develop guidance, templates,
and training materials to drive standardisation and best practices
Requirements
- Bachelor's degree in scientific or healthcare-related field
- Extensive clinical research, regulatory affairs, or ethics experience with informed consent focus
- In-depth knowledge of GCP, ethical principles, and global regulatory requirements
- Exceptional writing and editing skills for clear, patient-friendly documentation
- Strong stakeholder management and liaison experience with sponsors and ethics committees
- Proven ability to manage multiple complex studies with accuracy and ownership
📌 Senior Informed Consent Specialist (España)
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📍 España
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