Manager – Study Start Up

🕒 May 21

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

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 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

• Various annual leave entitlements • A range of health insurance offerings to suit you and your family’s needs. • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. • Life assurance • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.