Clinical Process Change Manager

ICON; Madrid; A distancia; EUR 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual leave entitlements

Health insurance

Retirement planning

LifeWorks (EAP)

Life assurance

Country-specific benefits

Descripción de la vacante

ICON Strategic Solutions is seeking a Clinical Process Change Manager to optimize and standardize procedural documentation across global trial operations. The role combines clinical operations expertise with quality and compliance to drive efficient, compliant execution of clinical development programs.

You will lead controlled document governance, manage complex cross-functional initiatives, and partner with senior leaders to ensure alignment with corporate standards and timelines.

Formación

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• 7-10+ years of Sponsor or CRO clinical research experience, ideally in late phase Clinical Operations or Quality Assurance.
• Deep understanding of Good Clinical Practice (GCP) and operational realities of global clinical trial execution.
• Experience managing complex cross-functional initiatives that require coordination, influence, and accountability without direct authority.
• Familiarity with procedural governance, controlled document management, CAPAs, quality systems, and change management.

Responsabilidades

• Manages and drives all aspects of controlled document development and revision with stakeholders, ensuring alignment with quality standards and business systems.
• Drives cross-functional initiatives related to business processes and department operations.
• Leads projects from initiation through implementation with clear timelines and ownership.
• Translates complex operational concepts into concise procedural language and facilitates meetings to drive decisions.

Conocimientos

Clinical operations

Project management

Process improvement

Facilitation

GCP knowledge

Educación

Bachelor's degree in a scientific discipline

Descripción del empleo

Clinical Process Change 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 process manager at ICON, you are in charge of a strategic process improvement professional who combines deep clinical operations expertise, exceptional project management skills, and a passion for simplifying ways of working while strengthening compliance.

You will be responsible for driving and managing all aspects of controlled document development, revision, and retirement, ensuring compliant, consistent, scalable, and efficient procedures and business processes by providing process expertise, and aligning cross-functionally with relevant stakeholders

What You Will Do:

The ideal Process Change Manager is a highly organized, detail-oriented, and influential professional who is passionate about improving how clinical development teams work. They possess a unique blend of clinical operations experience, quality and compliance expertise, process improvement capabilities, and strong facilitation skills. They thrive in complex, cross-functional environments where success depends on their ability to drive alignment, manage competing priorities, and deliver high-quality procedural documentation that enables efficient and compliant execution of clinical trials.

Key responsibilities include:

• Manages and drives all aspects of controlled document development and revision in collaboration with relevant stakeholders, ensuring alignment with quality standards, business systems and processes.
• Manages and drives cross-functional special initiatives and projects related to business processes and GCO department operations
• Drives projects proactively from initiation through implementation.
• Establishes clear timelines, roles, responsibilities, and decision points.
• Anticipates risks and obstacles before they impact delivery.
• Can simultaneously manage numerous document revisions at different stages of development.
• They are comfortable leading complex initiatives where progress depends on obtaining timely input, reviews, endorsements, and approvals from multiple stakeholders.
• Translate complex operational concepts into concise, clear procedural language.
• Facilitate meetings efficiently and keep discussions focused on decisions and outcomes.
• Navigate disagreement and drive consensus among stakeholders with competing perspectives
• Communicate effectively with senior leaders, functional SMEs, quality representatives, and operational teams
• Identify inconsistencies, gaps, ambiguities, and procedural risks quickly.
• Ensure documents are written clearly, logically, and in alignment with corporate standards
• Maintain rigor around version control, document formatting, references, workflows, and approval requirements

Your Profile:

The ideal Process Change Manager is a clinical operations and quality professional with deep quality and GCP knowledge and exceptional project management capabilities

Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• 7-10+ years of Sponsor or CRO clinical research experience, ideally within late phase Clinical Operations, Clinical Project Management, Quality Assurance, Process Excellence, or a related function.
• Deep understanding of Good Clinical Practice (GCP) and the operational realities of global clinical trial execution.
• Demonstrated experience managing complex cross-functional initiatives that require coordination, influence, and accountability without direct authority.
• Strong familiarity with procedural governance, controlled document management, CAPAs, quality systems, and change management principles
• Experience authoring, revising, reviewing, or governing procedural documents such as SOPs, Work Instructions, Templates, Forms, Job Aids, and Guidance Documents
• Lead cross-functional projects of high complexity with cross-functional team members within and outside department.

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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.

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

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