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

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 .

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