Clinical QA Senior Project Manager

ICON Strategic Solutions; United Kingdom; Hybrid; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning offerings

Global Employee Assistance Programme (

Life assurance

Job summary

ICON Strategic Solutions is seeking an experienced CQM- Principal Manager to lead clinical QA programs and drive procedural excellence across global trials. You will oversee SOPs, CAPA, and quality systems, collaborating with Clinical Operations, Quality, and Medical Affairs to maintain inspection readiness.

The role focuses on process improvement, complex project leadership, and stakeholder engagement to ensure compliant, scalable ways of working in a sponsor-dedicated model.

Qualifications

• Strong project management, communication, facilitation, and stakeholder management skills.
• Experience with GCP, ICH guidelines and global clinical trial conduct.
• Authoring and managing SOPs, procedures and controlled documents.

Responsibilities

• Lead development, revision, implementation, and retirement of controlled documents and SOPs.
• Drive cross-functional process improvement to enhance efficiency and compliance.
• Support inspection readiness and regulatory inspection activities.
• Lead quality event investigations, root cause analyses, CAPA development, and effectiveness checks.
• Manage complex projects with multiple stakeholders and timely delivery of objectives.
• Facilitate stakeholder alignment and influence process changes across global teams.
• Develop and deliver training to support compliance and capability.
• Monitor process performance and report progress to senior leadership.
• Mentor colleagues as a SME in procedural excellence and clinical quality.

Skills

Project management

Stakeholder management

Process improvement

Quality assurance

GCP & ICH knowledge

English communication

Education

Bachelor's degree in Life Sciences or related field

Tools

Veeva QMS

LMS platforms

Job description

CQM- Prinicpal 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.

What You Will Do

• 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.

What We're Looking For

• 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.

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.

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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here