[Hiring] Clinical QA Senior Project Manager @ICON plc

Role Description

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As a Clinical QA Senior Project Manager at ICON, you will be responsible for leading and managing 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.

What You Will Do:

• Manage day-to-day project and programme management activities, supporting your team to deliver quality outcomes.

Key Responsibilities:

• 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.

Qualifications

• 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.

Requirements

• Preferred Experience:
• 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.

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.
• Benefits may vary depending on role and location.