Clinical Process Change Manager

Remote Worker LTD.; United States; Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health & wellbeing

Retirement plan

Life assurance

Disability coverage

Training & development

Job summary

ICON Strategic Solutions is seeking a Clinical Process Change Manager to lead cross‑functional process improvements, focused on controlled document development, revision, and retirement in a compliant, scalable manner.

The role requires deep clinical operations experience, quality and GCP knowledge, and exceptional project management to align stakeholders and drive high-quality procedural documentation for efficient clinical trials.

Qualifications

• 7-10+ years of Sponsor or CRO clinical research experience
• Deep understanding of Good Clinical Practice (GCP) and operational realities of global clinical trial execution
• Experience managing complex cross-functional initiatives
• Familiarity with procedural governance, controlled document management, CAPAs, quality systems
• 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

Responsibilities

• Manages controlled document development and revision with stakeholders, ensuring alignment with quality standards
• Drives cross-functional initiatives related to business processes and GCO operations
• Leads projects from initiation through implementation with clear timelines and ownership
• Translates complex concepts into concise procedural language
• Facilitates meetings and drives decisions and outcomes
• Communicates with senior leaders and SMEs to gain input and approvals
• Maintains rigorous version control, references, and alignment with standards

Skills

GCP knowledge

Clinical research

Project management

Procedural governance

Change management

SOPs/Docs

Cross-functional leadership

Education

Bachelor's degree in a relevant scientific discipline

Job description

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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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.

Salary Range