Senior Informed Consent Specialist

ICON; Madrid; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning

Job summary

ICON, a global healthcare intelligence and clinical research organisation, seeks a Senior Informed Consent Specialist in Madrid, Spain. You will lead the development and oversight of consent strategies and documents for complex studies, ensuring ethical, compliant, and clear participant information.

You will mentor staff, oversee translation and regulatory liaison, and drive standardisation with templates and training across regions, collaborating with sponsors and ECs.

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.

Responsibilities

• 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, 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.

Skills

Informed consent

Clinical research

GCP knowledge

Editing/writing

Regulatory affairs

Stakeholder management

Communication

Education

Bachelor's degree in a relevant scientific discipline or healthcare-related field

Job description

Senior Informed Consent Specialist

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 values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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:

You will 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.

Your Profile:

You will have a strong foundation in scientific operations, with the experience to work independently and guide others.

Required qualifications and experience:

• 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.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment.

All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.