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Global drug and device development services

Informed Consent Specialist 2

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A bachelor's degree in a relevant scientific discipline or healthcare-related field is required.
  • Significant experience in clinical research, regulatory affairs, ethics, or a related function with a strong focus on informed consent is required.
  • In-depth knowledge of Good Clinical Practice (GCP), ethical guidelines, and global regulatory expectations relating to participant information and consent is required.
  • Strong writing and editing skills are required to convey complex information in clear, patient-friendly language.
  • Experience collaborating across functions and with external parties is required, along with stakeholder management and communication skills.
  • The ability to manage multiple studies and priorities with accuracy, accountability, and initiative is required.
  • Applicants must have the legal right to work in the country where the role is based.

Responsibilities

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

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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