Senior Clinical QA Project Lead – Process & Compliance

Remote Worker LTD.; United States; Remote; USD 120,000 - 190,000; Full time

Benefits offered by this job

Competitive salary & incentives

Health & wellbeing programmes

Retirement and pension plans

Life assurance and disability coverage

Employee assistance programmes

Learning & development opportunities

Job summary

ICON Strategic Solutions is seeking a Clinical QA Senior Project Manager to lead global clinical development programs, drive procedural excellence, and ensure inspection readiness across teams in a sponsor-dedicated model.

You will manage day-to-day project activities, develop and revise SOPs, support regulatory readiness, and mentor colleagues to strengthen clinical quality and operational effectiveness.

Qualifications

• Bachelor's degree in Life Sciences, Clinical Research, Healthcare, or related field.
• 7+ years of experience in biopharmaceutical, biotechnology, CRO, or clinical research.
• Strong background in clinical operations, quality, compliance, or process excellence.
• Deep understanding of GCP, ICH guidelines, and global clinical trial conduct.

Responsibilities

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

Skills

Project management

Stakeholder management

Communication

GCP knowledge

Process improvement

Training & mentoring

English proficiency

Education

Bachelor's degree in Life Sciences / Clinical Research / Healthcare

Tools

Veeva QMS

LMS platforms

Clinical development systems

Job description

ICON Strategic Solutions is seeking a Clinical QA Senior Project Manager to lead global clinical development programs, drive procedural excellence, and ensure inspection readiness across teams in a sponsor-dedicated model.

You will manage day-to-day project activities, develop and revise SOPs, support regulatory readiness, and mentor colleagues to strengthen clinical quality and operational effectiveness.