Site Monitoring Lead

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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 clinical trial management activities, supporting your team to deliver quality outcomes. • Leads RBM strategy meetings and develops study-specific site monitoring plan, aligned with study risk assessment. • Ensures monitoring strategies are configured in technology capabilities (e.g., TSDV). • Manages Site Monitoring assignments in client's systems (e.g., CDMS, CTMS). • Provides Site Monitoring training and supports the creation and delivery of initial and ongoing site monitoring materials. • Serves as primary reviewer of site monitoring visit reports, ensuring reports meet client's expectations. • Reviews systems and dashboards to assess site monitoring compliance. • Supports site monitoring needs during study conduct, including triggering monitoring visits. • Triggers and manages or conducts Monitoring Oversight Visits to assess site monitoring quality.

🎯 Requirements

• University degree in medicine, science, or equivalent combination of education & experience • Demonstrated ability to drive the clinical deliverables of a study • Minimum of 6 years of experience in the pharmaceutical or CRO industry • Minimum of 2 years of experience in Site Monitoring / Site Monitoring Management, Risk-Based Monitoring, or Monitoring Excellence roles • Robust understanding of drug development and clinical trial execution processes • Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6 (GCP) • 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