Country Study Operations Manager

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🔥 12 hours ago

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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

• Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close • May manage the study start up process in countries assigned • Oversees pCRO responsible for these activities as applicable • Provides country level input on Startup and Recruitment milestones • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution • Ensures compliance to relevant Global and Local, internal and external requirements and regulations • Timely communication between the global and local study teams • Supports the Country/investigator outreach process, site identification and feasibility • Acts as the study level point of contact for all study-level questions for the Local Study Team • Identifies country level trends to improve deliverables processes • Ensures audit/Inspection readiness during start-up and conduct

🎯 Requirements

• A scientific or technical degree is preferred along with knowledge of clinical trial methodology • BS/BSc/MS/MSc degree required • BA/BS 5+ years of relevant experience operational clinical trial experience • MBA/MS/ 3+ years of relevant experience operational clinical trial experience • Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility • Demonstrated clinical research experience and/or study management/startup project manager experience • Demonstrated experience in managing country level operational activities and/or vendors • Experience in Study and Quality management and working in a matrix management environment • Expertise in the use of study/site dashboard and reporting tools • Ability to operate in a matrix environment • Critical Path Analysis • Excellent communication skills, both written and verbal • Ability to adapt to changing technologies and processes • Effective verbal and written communication skills in relating to colleagues and associates.

🏖️ 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