Manager, Clinical Quality Compliance

PRA Health Sciences; Canada; Remote; CAD 80,000 - 120,000; Full time

Job summary

Join a leading global clinical research organization as a Manager in Global Clinical Quality. This role emphasizes quality assurance and compliance, requiring a problem-solver with strong leadership and collaboration skills. You will work closely with teams to ensure adherence to GCP standards and facilitate improvements across processes. With a commitment to continuous learning and employee growth, this forward-thinking company offers a comprehensive reward package and values diversity in the workplace. If you're ready to make an impact in clinical operations, this opportunity is for you.

Qualifications

• 5+ years in a Quality role within pharmaceutical or CRO.
• Experience with sponsor/site audits and process development.
• Strong communication and problem-solving skills.

Responsibilities

• Serve as point of contact for quality and compliance questions.
• Support team in risk mitigation and quality assurance.
• Collaborate to address quality issues with CROs.

Skills

Problem-solving

Leadership

Continuous improvement

Collaboration

Communication skills

Root cause analysis

Customer service orientation

Clinical Operations knowledge

Job description

As a Manager, Global Clinical Quality, you will join the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing :

• Serve as the point of contact for quality and compliance questions, working with QA to ensure alignment and consistent messaging based on GCP and regulatory requirements.
• Support the team in identifying, escalating, and implementing risk mitigation plans.
• Provide training to study teams as needed.
• Assist in preparing for regulatory inspections of sponsors, countries, sites, and vendors.
• Ensure adherence to GCP and overall quality standards as the global point of contact for sponsor study records.
• Support quality assurance within ongoing studies and submissions.
• Collaborate with teams to address quality issues with CROs and help bring them back into compliance.
• Contribute to the facilitation, presentation, and communication of lessons learned, and propose process improvements based on these insights.
• Review critical findings with QA audit reports to suggest process enhancements.
• Work with QA to gather information needed for global inspections.
• Review SOPs and WIs development.
• Support operational diagnostics to identify improvement opportunities.
• Provide input to Quality Plans and measure progress of improvement projects.
• Develop matrix relationships to involve process experts and conduct improvement activities.
• Ensure organizational alignment and integration.
• Stay informed of clinical trial requirements and guidelines from agencies like FDA, EMA, ICH GCP, and others.
• Become familiar with assigned compounds and protocols.
• Facilitate and support cross-functional stakeholder engagement.

Qualifications

You are :

• A problem-solver and leader committed to continuous improvement.
• Keenly knowledgeable of relevant procedures.
• Customer service oriented.
• A team player with strong collaboration skills.
• Experienced in managing complex operational challenges.
• Proficient at identifying issues, root cause analysis, and driving solutions.
• Excellent in verbal and written communication, effective with peers and all organizational levels.
• Broadly knowledgeable in Clinical Operations.

Minimum Qualifications

• At least 5 years’ experience in a pharmaceutical, bio-pharmaceutical, or CRO in a Quality role.
• Understanding of Clinical Operations activities.
• Experience with sponsor/site audits.
• Experience in process and SOP development.
• Strong communication skills.
• Willingness and ability to travel.

Why ICON?

Our focus is to provide a comprehensive and competitive total reward package, including base pay, variable pay, recognition programs, and employee benefits supporting your career and personal well-being.

We are committed to developing our employees through a continuous learning culture, offering engaging work and professional growth opportunities.

ICON is an equal opportunity and inclusive employer, dedicated to a workplace free of discrimination and harassment. We encourage all qualified applicants to apply, regardless of background or identity.

If you need accommodations during the application process or to perform job functions, please inform us.

Interested but unsure if you meet all requirements? We encourage you to apply — you might be exactly what we're looking for!