Senior Informed Consent Specialist

🔥 0 minutes ago

🏄 California, Pennsylvania – Remote

🏄 California – Remote 🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• 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

• 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

• 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