Clinical QA Senior Project Manager

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Clinical QA Senior Project Manager at ICON, you will be responsible for leading and manage projects, ensuring successful execution and delivery of project objectives.

We are seeking an experienced GCP QA Senior Project Manager to drive procedural excellence, quality, compliance, and operational effectiveness across global clinical development programs.

This is a highly visible, cross-functional role for a clinical operations professional who is passionate about process improvement, inspection readiness, and developing scalable, compliant ways of working. You will partner with stakeholders across Clinical Operations, Quality, and Medical Affairs to optimize processes, lead complex initiatives, and ensure clinical trials remain inspection ready.

• Lead the development, revision, implementation, and retirement of controlled documents, SOPs, work instructions, and guidance materials.
• Drive cross-functional process improvement initiatives that enhance efficiency, compliance, and operational excellence.
• 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 to support employee capability and compliance.
• 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.

• 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.
• Inspection readiness, audit support, or regulatory inspection experience.
• Quality systems, CAPA management, and deviation investigation experience.
• Experience with Veeva QMS, LMS platforms, or clinical development systems.

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.

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize…