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Clinical Process Change Manager

Job not on LinkedIn

đŸ”„ 7 minutes ago

🌐 United Kingdom, Spain, +4 more countries – Remote

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⏰ Full Time

🟠 Senior

🔮 Lead

👔 Manager

đŸ‘» Ghost score 10%

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Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

đŸ’Œ Consulting

đŸ„ 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

‱ Drive and manage all aspects of controlled document development, revision, and retirement ‱ Ensure compliant, consistent, scalable, and efficient procedures and business processes ‱ Provide process expertise and align cross-functionally with relevant stakeholders ‱ Manage cross-functional special initiatives and projects related to business processes and GCO department operations ‱ Drive projects proactively from initiation through implementation ‱ Establish clear timelines, roles, responsibilities, and decision points ‱ Anticipate risks and obstacles before they impact delivery ‱ Manage numerous document revisions at different stages of development ‱ Obtain timely input, reviews, endorsements, and approvals from multiple stakeholders ‱ Translate complex operational concepts into concise, clear procedural language ‱ Facilitate meetings and keep discussions focused on decisions and outcomes ‱ Navigate disagreement and drive consensus among stakeholders ‱ Communicate with senior leaders, functional SMEs, quality representatives, and operational teams ‱ Identify inconsistencies, gaps, ambiguities, and procedural risks ‱ Ensure documents align with corporate standards ‱ Maintain rigor around version control, document formatting, references, workflows, and approval requirements

🎯 Requirements

‱ Bachelor's degree in a relevant scientific discipline or healthcare-related field ‱ 7-10+ years of Sponsor or CRO clinical research experience, ideally within late phase Clinical Operations, Clinical Project Management, Quality Assurance, Process Excellence, or a related function ‱ Deep understanding of Good Clinical Practice (GCP) and the operational realities of global clinical trial execution ‱ Demonstrated experience managing complex cross-functional initiatives that require coordination, influence, and accountability without direct authority ‱ Strong familiarity with procedural governance, controlled document management, CAPAs, quality systems, and change management principles ‱ Experience authoring, revising, reviewing, or governing procedural documents such as SOPs, Work Instructions, Templates, Forms, Job Aids, and Guidance Documents ‱ Experience leading cross-functional projects of high complexity with cross-functional team members within and outside the department ‱ Legal right to work in the country where the role is based

đŸ–ïž 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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