Senior Manager, Risk Based Quality Management

Job not on LinkedIn

đź•’ September 30

🔔 Pennsylvania – Remote

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⏰ Full Time

đźź  Senior

🎲 Risk

đź‘» Ghost score 10%

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Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

đź’Ľ 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.

đź“‹ Description

• Oversee scientific operations, balancing quality, timelines, and stakeholder expectations • Develop and oversee clinical risk management strategies, including risk assessment, mitigation planning, and monitoring • Lead a team in identifying potential risks related to clinical trial operations, data integrity, and patient safety • Implement effective risk management measures • Collaborate with clinical operations, regulatory affairs, and data management teams • Monitor and analyze risk-related data and trends • Provide insights and recommendations to senior management • Ensure compliance with regulatory standards and industry best practices, including Good Clinical Practice (GCP)

🎯 Requirements

• Degree in Life Sciences, Medicine, Risk Management, or a related field • Extensive experience in clinical risk management or related roles, with a strong background in assessing and mitigating risks in clinical trials • Proven leadership skills, with experience managing and developing a team focused on risk management and patient safety • Expertise in regulatory requirements, industry standards, and risk management methodologies, with a solid understanding of clinical trial operations • Excellent analytical and problem-solving skills, with the ability to provide strategic recommendations and effectively communicate risk-related insights to stakeholders • Legal right to work in the country where the role is based

🏖️ 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

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