Informed Consent Specialist II

ICON; Madrid; On-site; EUR 52,000 - 62,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

EAP LifeWorks

Life assurance

Flexible country-specific benefits

Job summary

ICON is a global healthcare intelligence and clinical research organisation focused on bringing new medicines to patients faster. As an Informed Consent Specialist II, you will lead the development, review, and oversight of informed consent documents for complex, global clinical trials while guiding study teams on strategy and ensuring quality standards across regions.

You will work closely with sponsors, ethics committees, and regulatory bodies, oversee translations, and mentor junior staff,

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Significant experience in clinical research, regulatory affairs, ethics, or a related function with a strong focus on informed consent.
• In-depth knowledge of GCP, ethical guidelines, and global regulatory expectations relating to participant information and consent.
• Excellent writing and editing skills, with the ability to convey complex information in clear, patient-friendly language.
• Strong stakeholder management and communication skills, with experience collaborating across functions and with external parties.
• Proven ability to manage multiple studies and priorities, with a high level of accuracy, accountability, and initiative.

Responsibilities

• Leading the creation, review, and optimisation of global and local informed consent forms (ICFs) in alignment with protocol, regulatory, and sponsor requirements.
• Advising study teams on informed consent strategy, content, and country-specific considerations, including complex or high-risk studies.
• Overseeing translation processes, version control, and documentation to ensure consistency and traceability across regions.
• Interfacing with sponsors, ethics committees, and regulatory bodies to address queries and negotiate consent wording when required.
• Developing and maintaining guidance, templates, and best practices to drive standardisation and efficiency.
• Providing training and mentorship to junior team members on informed consent principles, processes, and quality standards.

Skills

GCP knowledge

Regulatory affairs

Writing skills

Stakeholder management

Multi-study management

Education

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

Job description

Informed Consent Specialist II

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 an Informed Consent Specialist II at ICON, you will take a lead role in the development, review, and oversight of informed consent documents for complex, global clinical trials.

What You Will Do:

Your role will involve delivering clinical research work to a high standard, working closely with your team and stakeholders.
Key responsibilities include:

• Leading the creation, review, and optimisation of global and local informed consent forms (ICFs) in alignment with protocol, regulatory, and sponsor requirements.
• Advising study teams on informed consent strategy, content, and country-specific considerations, including complex or high-risk studies.
• Overseeing translation processes, version control, and documentation to ensure consistency and traceability across regions.
• Interfacing with sponsors, ethics committees, and regulatory bodies to address queries and negotiate consent wording when required.
• Developing and maintaining guidance, templates, and best practices to drive standardisation and efficiency.
• Providing training and mentorship to junior team members on informed consent principles, processes, and quality standards.

Your Profile:

You will bring relevant clinical research experience, along with the following qualifications and skills.

Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Significant experience in clinical research, regulatory affairs, ethics, or a related function with a strong focus on informed consent.
• In-depth knowledge of GCP, ethical guidelines, and global regulatory expectations relating to participant information and consent.
• Excellent writing and editing skills, with the ability to convey complex information in clear, patient-friendly language.
• Strong stakeholder management and communication skills, with experience collaborating across functions and with external parties.
• Proven ability to manage multiple studies and priorities, with a high level of accuracy, accountability, and initiative.

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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

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply