Clinical Biospecimen Scientist

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🔥 9 minutes ago

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Logo of ICON plc

ICON plc

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

• Contribute input on clinical sample assessment sections in clinical trial documents, including protocols and consents • Create study-specific sample collection tables and align blood volumes needed versus allowed • Liaise with internal stakeholders to provide input on safety and PK sample collection and testing needs • Set up and oversee technical aspects of laboratories involved in kit building, sample management, and testing • Maintain related laboratory documentation, including lab manuals • Contribute input and solutions on ethical considerations for biospecimen collection and analysis • Manage samples and logistics with oversight from the Lead CBS • Collaborate with the Lead CBS to escalate trial-specific biospecimen collection and analysis risks and issues • Work fully embedded within a growing, global healthcare company • Implement and execute each GCO clinical study strategy for selected biospecimen samples

🎯 Requirements

• Previous CRO or vendor experience • Experience with human sample management, not only in-vitro sample management or animal testing management • Understanding of providing input on clinical sample assessments and requirements • Background in laboratory design from a clinical trial protocol perspective • Experience with central laboratory systems, laboratory builds, and data transfer specifications • Science degree • Laboratory background in sample management and sample processing • Understanding of assay requirements for samples in assigned studies • Experience with kit design and protocol contribution • Ability to communicate across multiple departments and line functions • Understanding of biospecimen collection requirements, collection timepoints, analysis, and data analysis • 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 • Reasonable accommodations during the recruitment process

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