Inform Consent Specialist

Icon Strategic Solutions; A distancia; MXN 400,000 - 600,000; Jornada completa

Descripción de la vacante

A global healthcare company is seeking a Senior Informed Consent Specialist to develop and review informed consent forms for clinical trials. This role demands strong knowledge of compliance guidelines and collaboration with cross-functional teams to ensure efficient study initiation. The ideal candidate will have over 3 years of ICF experience, solid English communication skills, and a detail-oriented approach. A competitive benefits package and a commitment to an inclusive workplace are offered.

Servicios

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Employee Assistance Programme

Life assurance

Flexible optional benefits

Formación

• Over 3 years of experience in informed consent writing and development.
• Proficient in ICH / GCP guidelines and related regulations.
• Excellent communication skills in English, both written and verbal.

Responsabilidades

• Develop and review informed consent forms for clinical trials.
• Ensure compliance with regulatory and company guidelines.
• Collaborate with various stakeholders on project outcomes.
• Mentor and coach new hires during onboarding processes.

Conocimientos

ICF writing

Strong English writing

Knowledge of ICH / GCP guidelines

Team collaboration

Analytical skills

Attention to detail

Descripción del empleo

Senior Informed Consent Specialist – Homebased – Mexico

ICON plc is a world-leading healthcare intelligence and clinical research organization. Join us on our mission to shape the future of clinical development.

We’re looking for a Senior Informed Consent Form (ICF) Specialist to ensure the accuracy, compliance, and timely approval of informed consent forms for clinical trials. This role supports the ethical conduct of research and successful study initiation.

Responsibilities

• Develop and review ICFs – prepare, review, and approve Subject Information Sheets (SIS) and Informed Consent Forms (ICF) for global master templates, country-specific versions, and site-specific adaptations.
• Ensure compliance – apply knowledge of ICON SOPs / WPs, ICH / GCP guidelines, and applicable country regulations related to Informed Consent.
• Stakeholder collaboration – serve as a key point of contact for Sponsors, SSU Project Managers, Clinical Trial Managers, and other functional leads to optimize performance and ensure successful project outcomes.
• Query resolution – review, negotiate, and approve all Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries related to country and site-specific ICFs.
• Timeline management – forecast and track SIS & ICF approval timelines, proactively identify risks, and develop contingency plans to mitigate potential impacts.
• Knowledge leadership – act as a Subject Matter Expert (SME) for assigned topics, stay updated on changing regulatory and language requirements affecting ICFs, and develop and conduct training.
• Documentation and archiving – ensure the accuracy and completeness of ICF documents transferred for filing into the Trial Master File (TMF).
• Mentorship – mentor and coach new hires during their onboarding process.
• Represent FSA – represent the department at audits, inspections, and on various committees and work groups.

Qualifications

• 3+ years of experience in ICF writing / development.
• Strong English writing and communication skills.
• Proficient knowledge of ICH / GCP guidelines and applicable country regulations related to Informed Consent.
• Ability to work collaboratively in a team environment and effectively communicate with diverse stakeholders.
• Strong analytical and problem‑solving skills, with excellent attention to detail.
• Protocol interpreting & review is preferred, but not required.

What ICON can offer you

Our benefits are designed to be competitive within each country and focus on well‑being and work‑life balance opportunities for you and your family. 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, TELUS Health, offering 24‑hour access to a global network of over 80,000 independent specialized professionals who support you and your family's well‑being.
• Life assurance
• Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, and others.

Inclusion & Belonging

We are 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 to perform the essential functions of a position, please let us know or submit a request here.

Apply

We encourage you to apply regardless of whether you meet every requirement – we value diverse talent and experience. If you are a current ICON employee, please apply through the internal portal. Otherwise, visit our careers site for more information and to submit your application.