Clinical Operations Specialist – Bilingual English/French

Syneos Health

Clinical Operations Specialist supporting multiple clinical studies across Canada in a fast-paced remote environment. Focused on regulatory submissions and compliance management for clinical trials across Health Canada.

Posted 7/3/2026full-timeRemote • 🇨🇦 CanadaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions to Health Canada, REBs, and IRBs, with a strong focus on compliance and inspection readiness. Proficient in managing multiple clinical protocols and maintaining accurate documentation in a remote environment.

Highest-signal resume keywords

Regulatory SubmissionsHealth Canada RegulationsClinical Trial Site Information (CTSI)Clinical Research ExperienceFluency in English and French

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document ManagementClinical Trial InvoicingStudy Documentation TrackingProtocol ManagementRegulatory Compliance

Soft Skills

Exceptional Organizational SkillsAttention to DetailAbility to Work Independently

Tools & Technologies

Study SystemsDatabases

Industry Keywords

Clinical OperationsResearch Ethics Boards (REBs)Institutional Review Boards (IRBs)Clinical Research

About the role

Key responsibilities & impact

Preparing and coordinating regulatory submissions to Health Canada, Research Ethics Boards (REBs), and Institutional Review Boards (IRBs).
Completing and maintaining Clinical Trial Site Information (CTSI) documentation.
Managing regulatory documents and study files to ensure compliance and inspection readiness.
Supporting multiple clinical studies simultaneously (typically 15+ active protocols).
Processing clinical trial invoices accurately and efficiently.
Tracking study documentation, regulatory milestones, and operational deliverables.
Working cross-functionally with clinical operations, regulatory, and study teams to ensure timely study execution.
Maintaining accurate records within study systems and databases.
Supporting study start-up, maintenance, and closeout activities while ensuring adherence to sponsor processes and regulatory requirements.

Requirements

What you’ll need

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 successfully manage 15 or more concurrent clinical protocols.
Exceptional organizational skills with strong attention to detail.
Ability to work independently in a fully remote environment while managing multiple priorities.

Benefits

Comp & perks

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to building an inclusive culture – where you can authentically be yourself.