Clinical Registry Coordinator

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

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

• Provides clinical registry support, oversight and/or accountability for one or more development programs for clinical trials. • Takes a leadership role with the clinical development team and other internal and external partners to establish, align and confirm clinical registry expectations for assigned trial(s). • Develops and delivers the Disclosure Plan with the CDTL and Patent attorney. • With the CDT and other functional partners: – Gathers content and integration requirements for registration records – Establishes expectations for dataset content and structure. – Set timelines and follow-up regularly to ensure delivery of all clinical trial disclosure milestones. • Responsible for submission of approved documents and content to registries worldwide. • Responsible for tracking, reporting and documentation of disclosure records and associated documents in tools and systems used by the clinical registry group. • Assisting business partners, external partners and local operating companies in maintaining accurate and correct (source) data, relevant to the disclosure process. • Ensures timely resolution of planning issues to ensure compliant delivery of the disclosure planning

🎯 Requirements

• A minimum of 4 years of relevant pharmaceutical/scientific experience in a clinical development environment (pharmaceutical, medical device, CRO or other clinical development service organization) is required. • Bachelor’s degree in Health or Science discipline with experience in clinical research (typical roles: clinical trial manager, regulatory submissions lead) • Clinical Registry experience preferred • Experience working on a clinical trial or regulatory document management preferred • Experience working in highly diverse teams within clinical research; cross-functional, global, multi-regional. • Project management skills. • Vendor management skills. • Advanced Microsoft Office skills including the ability to manipulate and analyze data

🏖️ 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