Informed Consent Specialist II

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

Benefits offered by this job

Annual leave

Health insurance

Retirement plan

Global EAP LifeWorks

Life insurance

Flexible benefits

Job summary

ICON is seeking an Informed Consent Specialist II in Madrid to lead the development, review, and oversight of informed consent documents for complex, global clinical trials.

You will advise study teams on consent strategy, oversee translations and documentation, and liaise with sponsors and ethics committees to ensure compliant consent wording. The role includes mentoring junior staff and shaping best practices across regions.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Significant experience in clinical research, regulatory affairs, ethics, or related function with 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, able to convey complex information clearly for patients.
• Strong stakeholder management and cross-functional collaboration skills.
• Proven ability to manage multiple studies with accuracy, accountability and initiative.

Responsibilities

• Lead the creation, review, and optimisation of global and local informed consent forms in line with protocol, regulatory and sponsor requirements.
• Advise study teams on informed consent strategy, content, and country-specific considerations.
• Oversee translation processes, version control, and documentation for regional consistency and traceability.
• Interface with sponsors, ethics committees, and regulatory bodies to address queries and negotiate consent wording.
• Develop and maintain guidance, templates, and best practices to standardise and improve efficiency.
• Provide training and mentorship to junior team members on informed consent principles and quality standards.

Skills

Clinical research

Regulatory affairs

GCP knowledge

Writing & editing

Stakeholder management

Multi-study management

Education

Bachelor's degree in a scientific/healthcare 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.

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 (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable-accommodations)