Project Specialist

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🕒 June 10

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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

• Be a key member of the sponsor's Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness • Responsible for budget oversight – managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the Project Manager • Responsible for country oversight, acting as a primary point of contact, tracking recruitment progress, data completeness and compliance, overseeing local budgets, protocol deviations, risks, regulatory approvals and import license status • Vendor management and CRO oversight, acting as a primary point of contact, overseeing study-specific deliverables • Data oversight, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination) • Maintain interactions and meetings with internal and external partners • Responsible for reviewing key clinical documents, including the Protocol and Informed Consent Forms, and leading development of study plans (e.g. Monitoring Plan, Vendor Management Plan, etc.) for external and internal use in assigned studies • Monitoring study conduct and progress, identifying, resolving and escalating risks/issues • Responsible for setting up and maintaining systems and tracking tools that ensure quality, consistency and integration of study data, following up on discrepancies if needed • Grant access to new system users.

🎯 Requirements

• Life Science degree • 1+ years of clinical trial experience within clinical research • Experience in global project management/supporting global cross-functional teams at study level would be an advantage • Experience working with eTMF and CTMS • Fluent English • Very good comprehension of Microsoft Office tools (Excel, PowerPoint, Word, Outlook, etc.) • Knowledge of advanced Excel, timelines/budget tracking systems and clinical trial management systems is an asset. • Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills.

🏖️ 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