Study Start Up Associate II

🔥 0 minutes ago

🌐 United Kingdom, Ireland – Remote

🇬🇧 United Kingdom – Remote 🇮🇪 Ireland – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

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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 initiation of clinical trials, ensuring compliance with regulatory requirements • Contribute to site start-up and activation activities, taking responsibility for deliverables and working collaboratively • Work directly with assigned sites on essential document collection and review • Partner with the internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve SSU metrics and deliver processes • Ensure standards are applied to SSU processes across projects • Review site essential documents for start-up, including ICF, FDF, 1572, and CVs • Recognize and improve potential site activation delays and escalate to appropriate team members • Track actions and communications with sites to achieve study and site timelines • Support resolution of escalated issues identified by CROs and Clinical Operations teams with the internal Study Startup team • Review and provide feedback to management on site performance metrics • Ensure accuracy and completeness of the eTMF for assigned sites during start-up

🎯 Requirements

• BS degree or international equivalent • 2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO, or relevant industry vendor • Ability to explain data to facilitate data-driven decision-making processes • Knowledge and understanding of clinical study protocols and essential documents • Strong organizational, decision-making, communication, and negotiation skills • Proficient in Microsoft Excel, Word, and PowerPoint • Legal right to work in the country where the role is based

🏖️ Benefits

• Competitive base salary • 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