Clinical Operations Specialist; Sponsor Dedicated – Remote Bilingual English​/French

Clinical Operations Specialist (Sponsor Dedicated) – Remote, Canada (Bilingual English/French)

Are you a bilingual Clinical Operations professional with deep expertise in Health Canada regulatory submissions and clinical trial operations? We’re seeking an experienced Clinical Operations Specialist to join our growing Sponsor Dedicated team in a fully remote role across Canada, supporting multiple clinical studies with excellence and compliance.

• Prepare and coordinate regulatory submissions to Health Canada, Research Ethics Boards (REBs), and Institutional Review Boards (IRBs).
• Complete and maintain Clinical Trial Site Information (CTSI) documentation.
• Manage regulatory documents and study files to ensure compliance and inspection readiness.
• Support multiple clinical studies simultaneously (typically 15+ active protocols).
• Process clinical trial invoices accurately and efficiently.
• Track study documentation, regulatory milestones, and operational deliverables.
• Work cross‑functionally with clinical operations, regulatory, and study teams to ensure timely study execution.
• Maintain accurate records within study systems and databases.
• Support study start‑up, maintenance, and close‑out activities while ensuring adherence to sponsor processes and regulatory requirements.

• Fluency in both English and French (written and spoken).
• Approximately 3+ years of clinical operations, clinical project associate, or equivalent clinical research experience.
• Strong working knowledge of Health Canada regulations.
• Extensive experience preparing and submitting regulatory packages to Health Canada.
• Experience with Research Ethics Board (REB) and/or Institutional Review Board (IRB) submissions.
• Hands‑on experience completing Clinical Trial Site Information (CTSI) forms.
• Experience processing clinical trial invoices.
• Ability to manage 15 or more concurrent clinical protocols.
• Exceptional organizational skills with strong attention to detail.
• Capacity to work independently in a fully remote environment while managing multiple priorities.

• Experience as a Clinical Project Associate (CPA), Clinical Operations Specialist, Senior Clinical Specialist, Site Activation Specialist, or other clinical research professional with significant regulatory responsibilities.
• Experience as a Study Coordinator with substantial regulatory submission experience involving Health Canada and REB processes.

• Fully remote work within Canada.
• Opportunity to support a leading global pharmaceutical program.
• Collaborative, supportive team environment.
• Meaningful work that directly contributes to advancing clinical research.
• Professional growth and development opportunities.

The Company is committed to compliance with the Americans with Disabilities Act and provides reasonable accommodations for employees and applicants as needed.