Audit Operational Specialist

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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

• Contribute to quality assurance and compliance activities, taking responsibility for your deliverables and working collaboratively • Embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs • Perform Quality Management Review (QMR) on active projects • Extract and review study data from the SQL database to ensure accuracy according to system specifications and client requirements • Communicate with department management and project managers regarding quality and/or compliance issues and trends • Conduct accurate and timely secondary review of QMRs • Act as subject matter expert for compliance staff in specialized tasks

🎯 Requirements

• Bachelor's degree in a related field (e.g., Life Sciences, Regulatory Affairs, or Compliance) • Relevant experience in compliance, quality management, or a related field within the Interactive Technologies division • Proficiency in performing Quality Management Reviews (QMR) on active projects, ensuring adherence to established quality standards and procedures • Strong communication skills to effectively convey quality and compliance issues and trends to department management and project managers • Perform accurate and timely secondary reviews of QMRs, identifying discrepancies and recommending corrective actions • Act as a subject matter expert for compliance staff, providing guidance and support in specialized compliance tasks • Collaborate effectively with cross-functional teams and colleagues to ensure compliance goals are met • Willingness to travel as required (approximately 10%)

🏖️ 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