Clinical Operations Excellence Lead (COEL) - Home-Based (US or Canada)

The Clinical Operations Excellence Lead (COEL) is responsible for the operational implementation of the clinical Quality Management System (QMS) within the Global Clinical Operations organization (including Global Trial Operations, Data Management, Medical Writing, and Global Sourcing & Alliance Management). This will be done in alignment with the global quality strategy, ensuring consistency, effectiveness, and efficiency. The ideal candidate will excel in leadership, cultivating strong internal and external relationships, and fostering effective communication.

• Oversee the adequacy of processes within Global Clinical Operations, ensuring that regulatory requirements and commitments are reflected in procedural documents.
• Drive continuous improvement initiatives for processes and systems within Global Clinical Operations.
• Integrate quality risk management principles into all processes and systems to support compliance and ensure inspection readiness.
• Lead investigations and the development of Corrective and Preventive Action (CAPA) plans in response to process-level non-compliances, audit, and inspection findings within Global Clinical Operations.
• Foster a culture of feedback regarding non-compliance, CAPA, and audit/inspection findings, identifying opportunities to share knowledge and expertise.
• Contribute to defining and monitoring compliance and quality metrics to ensure oversight of Global Clinical Operations processes and projects.
• Prioritize clinical process improvement activities by applying Quality Risk Management and Quality-by-Design principles consistently.
• Identify and implement innovative technologies and methodologies to enable quality-by-design in clinical study activities.
• Serve as an active member of the Global Clinical Operations leadership team to ensure alignment across functions and regular reviews of inspection readiness status.
• Lead or contribute to cross-functional and cross-company initiatives that improve quality and compliance while reducing rework.
• Ensure alignment with the Quality Assurance (QA) organization.
• Act as a liaison between Global Clinical Operations and other stakeholder organizations/functions within clinical development.
• Foster collaborative relationships with partnering organizations such as QA, BIS, Clinical Development, GPS, and GRA.

• Bachelor’s degree or equivalent in a medical or para-medical field (e.g., Biology, Biomedical Sciences, Pharmacy, Veterinary, etc.), or equivalent experience.
• A minimum of 10 years of experience in Clinical Quality Management.
• Working knowledge of the regulatory obligations and relationships between pharmaceutical/biotech companies and Contract Research Organizations (CROs).
• Experience in global strategic drug development.
• Extensive experience with GCP quality management systems, regulatory rules and guidelines, medical terminology, clinical trials, and drug development.
• Strong interpersonal, negotiation, and leadership skills.
• Excellent written and verbal communication skills, with experience working in a culturally diverse, global team.
• Ability to work independently and effectively prioritize tasks.
• Expertise in Root Cause Analysis, CAPA development, and Risk Management methodology.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.