Biosampling Project Manager

🔥 0 minutes ago

🌐 Bulgaria, Romania, +2 more countries – Remote

🇧🇬 Bulgaria – Remote 🇷🇴 Romania – Remote 🇪🇸 Spain – Remote 🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 10%

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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

• Implement biosample and laboratory strategies for assigned clinical studies, ensuring timely delivery and optimal quality • Provide study-level oversight of laboratories/vendors involved in biosampling activities and analyses; contribute to laboratory selection processes • Manage operations for biosampling activities, ensuring timely data delivery in collaboration with stakeholders during study conduct • Provide regular study-level updates to Biosampling Project Leaders, Study Management Teams, and other stakeholders • Deploy sample management strategies and oversee laboratory activities, including technical qualification, sample analysis plans, validations, and analytical reports • Contribute to site-level feasibility and selection processes related to sample collection, processing, and shipping requirements • Provide and/or review sample handling training and relevant reference materials for clinical studies • Provide input to protocol and informed consent design to ensure logistical feasibility and compliance with regulatory, legal, and ethical guidelines • Ensure alignment of biosampling setup with Dx Operations for assays overseen by DX groups • Ensure appropriate sample quality, define corrective actions for study issues, and escalate issues when necessary • Contribute to functional process and system improvements to drive operational excellence

🎯 Requirements

• Experience in clinical trial specimen management, including collection/processing of diverse sample types, laboratory management, LIMS, and project management • Knowledge of the clinical development process, GxP, and global regulatory requirements • Strong communication, interpersonal, and matrix working skills • Self-motivated and able to work independently, with a proactive attitude and ability to collaborate effectively within multidisciplinary teams • Demonstrated knowledge of global regulatory requirements for sample analysis, including sample exportation • Bachelor’s degree in a science or health-related discipline • Experience with validation and implementation of biomarkers • 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