Clinical QA Senior Project Manager

Remote Worker LTD.; United States; Remote; USD 120.000 - 190.000; Vollzeit

Benefits dieser Stelle

Competitive salary & incentives

Health & wellbeing programmes

Retirement and pension plans

Life assurance and disability coverage

Employee assistance programmes

Learning & development opportunities

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Project management

Stakeholder management

Communication

GCP knowledge

Process improvement

Training & mentoring

English proficiency

Ausbildung

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

Tools

Veeva QMS

LMS platforms

Clinical development systems

Jobbeschreibung

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:

You will 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.

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.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.