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

Syneos Health•Unorganized Thunder Bay District, ON

1d•Remote

About The Position

Syneos Health is a leading life sciences services organization that partners with innovators across the drug development and commercialization continuum. The Clinical Solutions team members act with a drug development mindset, applying their expertise to understand customer needs and shape solutions. In this role, you will be part of a Sponsor Dedicated team, collaborating with passionate problem solvers to help customers achieve their goals. The company is agile and driven to deliver for its employees, customers, and patients. Syneos Health is committed to developing its people through career development, training, and a supportive environment, fostering an inclusive culture where employees can be authentic. The purpose 'Driven to Deliver' captures the passion of colleagues to shape solutions that dramatically impact lives. The company is continuously building a desirable workplace and aims to shape the future of healthcare by bringing together smart colleagues globally.

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 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.

Nice To Haves

Clinical Project Associate (CPA)
Clinical Operations Specialist
Senior Clinical Specialist
Site Activation Specialist
Clinical Research professional with significant regulatory responsibilities
Candidates who have worked as Study Coordinators are encouraged to apply if they have substantial regulatory submission experience, particularly involving Health Canada and REB processes.

Responsibilities

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.