Clinical Trial Manager (Regulatory) - Montreal

About the role

ICON, a global healthcare intelligence and clinical research organisation, is hiring a Clinical Trial Manager (Clinical Operations Manager - Regulatory) in Montreal. The role is accountable for performance and compliance of assigned protocols under ICH/GCP, country regulations, sponsor policies and quality standards, and covers budget, country submissions and approvals and site readiness. It reports to the Senior Clinical Operations Manager.

Key responsibilities

• Own country and site budgets, negotiate and complete Clinical Trial Research Agreements, track payments and reconcile them at closeout.
• Oversee FCPA, DPS/OFAC compliance and maintain financial systems, with financial forecasting.
• Execute and oversee country submissions and approvals, develop local informed consents and translations, and liaise with IRB/IEC and regulatory authorities.
• Manage country deliverables, timelines and results, contribute to local SOPs, and coordinate with CRM, CTC, CRA, finance and legal teams.
• Support local vendors, manage clinical and ancillary supplies, import/export, filing, archiving, retention and insurance, and enter country data in clinical and finance systems.
• Influence investigators and partners, work with headquarters on country timelines, and act as subject matter expert and mentor for the team.

Required profile

• Bachelor's degree in Business Finance/Administration/Life Sciences or equivalent healthcare experience.
• 5 years in clinical research, or combined clinical research and finance/business experience.
• Eligible to work in Canada without visa sponsorship.

Required skills

• Core clinical systems, tools and metrics.
• Budget and contract negotiation, local regulatory environment and submission/approval processes.
• French and English, with strong influencing, coordination and mentoring skills.

What we offer

• Competitive base salary and performance-related incentives.
• Medical, dental and vision coverage where applicable, retirement and pension plans, life assurance and disability coverage.
• Employee assistance programmes, learning and development opportunities.