Study Start-Up Lead

🔥 0 minutes ago

🌐 Spain, United Kingdom, +2 more countries – Remote

🇪🇸 Spain – Remote 🇬🇧 United Kingdom – Remote 🇧🇬 Bulgaria – Remote 🇵🇱 Poland – Remote

⏰ Full Time

🟠 Senior

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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

• Contribute SSU insights to the trial Operational Execution Plan and align the SSU plan and strategy with the Study Leader/Clinical Trial Team • Configure and ensure trial-specific set-up of SSU systems, including eTMF, CTMS, milestones, tasks, vendors, translations, countries, enrollment, contracting, budgeting, and ICF tools • Prepare global SSU planning and lead the SSU Team from kick-off through completion of study start-up • Ensure timely collection and eTMF filing of global trial-level documents for health authority and Ethics Committee submissions and site activation • Support the Vendor Program Manager with global vendor activation and health authority submission documents • Ensure global Protocol and ICF templates are ready for country use, including translations • Direct investigator grant planning, fair-market-value assessment, and country site budget and contract template readiness • Maintain global accountability for study start-up TMF timelines, accuracy, quality, and inspection readiness

🎯 Requirements

• Must have the right to work in the UK, Spain, Poland, or Bulgaria • Relevant experience in a similar role, ideally within a senior SSU role • Experience working within the Clinical Research, Biotech, or Pharmaceutical industry • Ability to start a new role within 4–8 weeks is highly advantageous

🏖️ 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