Study Start-up Lead

Job not on LinkedIn

🔥 0 minutes ago

🌲 North Carolina, Pennsylvania – Remote

🌲 North Carolina – Remote 🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

👻 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

• Manage and conduct country-level study start-up activities in compliance with client procedures, ICH-GCP, and relevant regulations. • Prepare, review, track, and manage site regulatory documentation at country and site level. • Maintain, review, and report on site performance metrics. • Collaborate with CRAs and the Local Study Team/Local Study Associate Director to achieve study start-up activities and milestones. • Contribute to clinical and operational feasibility assessments. • Manage collection, preparation, review, and tracking of documents for regulatory applications. • Submit applications and documents to Regulatory Authorities and/or IEC/IRB during start-up. • Participate in Local Study Team meetings. • Update CTMS and other systems with study-site data within required timelines. • Follow up on outstanding actions with study sites to ensure timely resolution. • Collect and upload essential documents into the eTMF and support quality-control checks. • Provide country-level updates to Line Managers on study milestones and key issues.

🎯 Requirements

• Bachelor’s Degree, preferably in life sciences. • Minimum of 5 years of experience in a Clinical Research environment, focusing on Start-Up. • Strong project management skills, with a deep understanding of regulatory and submission processes • Excellent written and verbal communication abilities. • Proven ability to work efficiently to tight deadlines and manage multiple priorities. • 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