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ICON plc

Senior Informed Consent Specialist

ICON plc

. Lead the development and oversight of informed consent strategies and documents for complex, global clinical studies .

Posted 9/21/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in developing informed consent strategies and documents for complex clinical studies, ensuring compliance with global regulatory expectations and ethical principles. Strong ability to mentor and lead teams while managing multiple projects with accuracy and ownership.

Highest-signal resume keywords
Informed Consent Strategy DevelopmentClinical Research ExperienceGCP KnowledgeStakeholder ManagementExceptional Writing Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Informed Consent Document CreationRegulatory Affairs ExpertiseEthical Principles KnowledgeTranslation OversightVersion Control Management
Soft Skills
MentoringCross-Functional CollaborationNegotiation Skills
Industry Keywords
Clinical StudiesGlobal Regulatory ExpectationsPatient-Friendly DocumentationIRB/EC LiaisonContinuous Improvement Initiatives

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • Lead the development and oversight of informed consent strategies and documents for complex, global clinical studies
  • Take ownership of scientific operations deliverables, applying expertise to complex challenges
  • 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, including readability, cultural considerations, and local regulatory expectations
  • Oversee translation, localisation, and version control processes 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 within the informed consent function
  • Mentor junior informed consent specialists and contribute to continuous improvement initiatives

Requirements

What you’ll need
  • 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
  • Legal right to work in the country where the role is based

Benefits

Comp & perks
  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways