Study Start Up Manager

🕒 6 days ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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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

• You will manage day-to-day site start-up and activation activities, supporting your team to deliver quality outcomes. • Managing and overseeing the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation. • Leading a team of study start-up professionals, providing guidance, mentorship, and support to ensure high performance and successful project delivery. • Collaborating with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation. • Monitoring study start-up metrics, timelines, and budgets to ensure projects are delivered on time and within scope. • Identifying potential risks and challenges in the start-up process and implementing strategies to mitigate delays or issues. • Driving continuous improvement initiatives to optimize the study start-up process and enhance overall efficiency.

🎯 Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field • Extensive experience in clinical trial study start-up, with a strong understanding of global regulatory requirements and clinical operations. • Proven leadership skills, with experience managing and mentoring teams in a fast-paced, deadline-driven environment. • Excellent organizational and project management skills, with the ability to handle multiple studies and priorities simultaneously. • Strong communication and stakeholder management skills, with the ability to collaborate effectively with sponsors and internal teams. • Experience with process optimization and implementing best practices in study start-up activities. • Willingness to travel as required (approximately 25%)

🏖️ 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