Clinical Quality Compliance Lead

ICON; Canada; Remote; CAD 90,000 - 130,000; Full time

Job summary

ICON, a leading clinical research organization, seeks a Clinical Quality Compliance Lead to ensure inspection readiness and compliance across studies. The role involves guiding teams, managing documentation, and monitoring compliance metrics, requiring extensive experience in clinical research and GCP knowledge. Join us to contribute to innovative healthcare solutions while enjoying competitive benefits and a focus on work-life balance.

Benefits

Annual leave entitlements

Health insurance options

Retirement plans

Global Employee Assistance Programme

Life assurance

Flexible benefits such as childcare vouchers

Gym discounts

Travel passes

Qualifications

• Minimum 6+ years of clinical research experience in pharma or biotech.
• Strong knowledge of GCP compliance and study processes.
• Experience with CROs and outsourced trials.

Responsibilities

• Provide guidance on inspection readiness and compliance.
• Manage inspection readiness planning and tools.
• Monitor compliance signals and study health metrics.

Skills

GCP compliance

Project management

Communication

Problem solving

Negotiations

Education

Bachelor’s degree

Tools

Microsoft Office

Project management tools

Veeva

Job description

As a Clinical Quality Compliance Lead, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

What you will be doing:

1. Provide guidance to study teams on key operating model processes and documentation, focusing on inspection readiness.
2. Manage inspection readiness planning, developing plans and tools in collaboration with cQA and GCP Excellence teams.
3. Develop inspection deliverables such as listings, presentations, storyboards, and audit preparations.
4. Monitor compliance signals and study health metrics to address issues proactively.
5. Engage Sponsor and CRO SMEs in inspection activities and risk assessments.
6. Oversee TMF performance and processes, ensuring compliance and readiness, including cross-functional and outsourced elements.
7. Lead and participate in strategy and core team meetings for projects.
8. Maintain effective communication and escalate issues with vendors.
9. Manage project documentation such as plans, timelines, and progress reports.
10. Coordinate activities for study team readiness for audits and inspections.
11. Manage inspection teams, collaborate with SMEs, and ensure timely responses.
12. Facilitate and monitor CAPA activities with GCP Compliance and QA.
13. Identify and implement process improvements for inspection readiness and study execution.
14. Provide regular updates to stakeholders and leadership.
15. Ensure alignment with SMEs and cQA throughout the study lifecycle and during inspections.

You are:

1. Minimum 6+ years of clinical research experience in pharma or biotech.
2. Strong knowledge of GCP compliance, inspections, and study processes.
3. Experience with CROs and outsourced trials; sponsor experience preferred.
4. Understanding of drug development and clinical trial standards.
5. Experience with clinical systems management (Veeva preferred).
6. Awareness of sponsor oversight and regulatory requirements.
7. Excellent project management and communication skills.
8. Ability to work in a fast-paced, changing environment, managing multiple tasks.
9. Bachelor’s degree preferred or equivalent experience.
10. Proficiency in Microsoft Office and project management tools.

Experience in problem solving, negotiations, and team collaboration is required.

What ICON can offer you:

Our success depends on our people. We value diversity, high performance, and talent development.

In addition to a competitive salary, ICON offers benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement plans
• Global Employee Assistance Programme
• Life assurance
• Flexible benefits such as childcare vouchers, gym discounts, and travel passes

Visit our careers site for more: https://careers.iconplc.com/benefits

ICON is committed to inclusion and diversity. We provide an accessible environment and equal opportunity for all applicants. For accommodations during the application process, please visit: https://careers.iconplc.com/reasonable-accommodations

Interested but unsure if you meet all requirements? We encourage you to apply – you may be exactly what we’re looking for.