Study Start Up Associate II

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 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

• Lead the initiation of clinical trials • Contribute to site start-up and activation activities • Prepare and submit regulatory packages • Collect and manage essential documents • Conduct quality review of study documentation • Support day-to-day assigned SSU activities in compliance with GCP/ICH guidelines and regulatory requirements • Communicate and coordinate with key business stakeholders and study teams • Support site activation activities, MOH/IRB/EC submissions, and ICF country/site customization • Generate and provide accurate project status and financial information in tracking systems/tools • Identify and escalate issues related to SSU deliverables • Execute assigned SSU activities • Support implementation of standards for the global SSU team

🎯 Requirements

• BS/BA degree or Associates degree with ≥3 years of experience in the health care field or direct clinical trial related experience • Knowledge of clinical trial conduct • Experience with IVDR studies • General knowledge of drug development and ICH/GCP guidelines • Proven project management skills • Familiarity with Veeva Vault TMF and Veeva CTMS • Excellent interpersonal, written and verbal communication skills • Administrative skills and computer ability • Fluent in English • 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