Clinical QA Senior Project Manager – Process Excellence

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

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.