Clinical Operations Specialist – Bilingual English/French

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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

• 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

• 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.