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Senior Clinical QA Project Manager

Job not on LinkedIn

đź•’ Yesterday

🇬🇧 United Kingdom – Remote

⏰ Full Time

đźź  Senior

👷‍♀️ Project Manager

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

• Lead and manage projects, ensuring successful execution and delivery of project objectives • Manage day-to-day project and programme management activities • Lead the development, revision, implementation, and retirement of controlled documents, SOPs, work instructions, and guidance materials • Drive cross-functional process improvement initiatives • Partner with Quality Assurance and Clinical Operations teams to support inspection readiness and regulatory inspection activities • Lead quality event investigations, root cause analyses, CAPA development, and effectiveness checks • Manage complex projects involving multiple stakeholders and ensure timely delivery of business objectives • Facilitate stakeholder alignment and influence process changes across global teams • Develop and deliver training, onboarding, and learning initiatives • Monitor process performance, identify improvement opportunities, and report progress to senior leadership • Mentor colleagues and serve as a subject matter expert in procedural excellence and clinical quality

🎯 Requirements

• Bachelor's degree in Life Sciences, Clinical Research, Healthcare, or a related field • 7+ years of experience within the biopharmaceutical, biotechnology, CRO, or clinical research industry • Strong clinical operations, quality, compliance, or process excellence background • Deep understanding of GCP, ICH guidelines, and global clinical trial conduct • Demonstrated experience leading cross-functional projects and process improvement initiatives • Experience authoring and managing SOPs, procedures, work instructions, or other controlled documents • Excellent project management, communication, facilitation, and stakeholder management skills • Strong written and verbal English communication skills • Sponsor-side clinical research experience preferred • Inspection readiness, audit support, or regulatory inspection experience preferred • Quality systems, CAPA management, and deviation investigation experience preferred • Experience with Veeva QMS, LMS platforms, or clinical development systems preferred • 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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