Process, Training and Execution Lead

Manager, Quality Assurance

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 Process, Training and Execution Lead at ICON, you will ensure the quality and compliance of clinical trials, interpreting regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

What You Will Do

This role will be responsible for executing the implementation strategy for the Development organization and working closely with the Process, Training & Execution team, Clinical Compliance, R&D Quality and Risk Management, and on SOP strategy and deployment to support the organization in being in a proactive state of inspection readiness. The successful candidate will have experience in process development and management and SOP strategy. The ability to effectively collaborate and organize in a fast paced and results oriented environment, combined with a passion for Development, is a must. Applicants should be collaborative team members with the ability to effectively lead a team and communicate with internal and external stakeholders.

Key responsibilities include

• Work with the Process and Training team to drive the development, optimization, implementation, and maintenance of Development processes, controlled documents, training, and supporting tools.
• Draft, revise, and maintain controlled documents, including SOPs, work instructions, policies, and associated templates, in collaboration with Business Process Owners, subject matter experts, Quality, and other cross-functional stakeholders.
• Coordinate document quality control (QC) and formatting activities, ensuring controlled documents meet applicable document standards and are ready for review, approval, and implementation.
• Manage controlled documents through the Veeva document lifecycle and workflow, including document creation, review and approval coordination, comment resolution, version management, and preparation for effective implementation.
• Facilitate and coordinate cross-functional working sessions to gather requirements, resolve stakeholder feedback, and drive controlled documents and process changes to completion.
• Support development and implementation of training and role-based learning associated with new or revised processes and controlled documents.
• Provide GxP/GCP and process expertise to support compliant, inspection-ready clinical trial processes and documentation.
• Drive adoption of AI-enabled ways of working across Process, Training & Execution, identifying opportunities to improve the efficiency, consistency, and quality of process development, document authoring, training, and related activities
• Develop, test, implement, and maintain AI-enabled tools and solutions that support process management, controlled document development, training, and other PTE activities, in accordance with applicable governance and requirements.
• Analyze existing processes, systems, and tools and recommend opportunities for simplification, automation, standardization, and continuous improvement.
• Track and communicate key deliverables, milestones, timelines, KPIs, and risks associated with assigned process, document, and training initiatives.
  
  Required qualifications and experience:
• BA/BS required; Applicable experience will be considered in lieu of education; Advanced degree preferred
• Minimum of 10+ years of experience in a clinical research environment within the pharmaceutical and biotech industry
• Demonstrated ability to independently drive complex cross-functional deliverables from development through implementation
• Demonstrated experience drafting and managing GxP controlled documents, including SOPs, work instructions, policies, and templates
• Experience with Veeva QualityDocs or similar electronic document management systems, including document workflows, review/approval cycles, and document lifecycle management
• Strong technical writing, editing, document QC, and stakeholder facilitation skills
• Experience applying AI, automation, or emerging technologies to improve business processes, document development, training, or knowledge management preferred
• Ability to translate complex regulatory, quality, and operational requirements into clear, practical processes and controlled documentation
• Solid understanding and working knowledge of Contract Research Organizations, third-party vendors that support clinical trials, and relationship management
• Strong understanding of appropriate regulations and guidelines (e.g., FDA and ICH GCP guidelines) and applicability to clinical trials

• Outstanding verbal and written communication skills
• Ability to manage multiple projects in a fast-paced environment
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment

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

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply