Senior Study Start-Up Specialist

📋 Description

• Lead and coordinate study start-up activities from site selection through activation, including
• Contribute to site feasibility discussions and support informed site-selection decisions.
• Manage initial and ongoing submissions while ensuring activities are delivered accurately, on time
• Prepare and submit documentation to central IRBs and support timely review and approval.
• Coordinate the preparation, collection, review, negotiation, and management of essential study
• Build on existing site relationships and partnership data to improve start-up efficiency and reduce

🎯 Requirements

• Bachelor’s degree or higher in a scientific, healthcare, or related discipline preferred.
• At least 3 years of progressive experience in clinical research and clinical operations.
• Experience within biotechnology, pharmaceutical, CRO, or clinical-site environments is preferred.
• Strong working knowledge of ICH/GCP requirements, relevant country regulations and guidelines, and
• Demonstrated experience with study start-up, site activation, regulatory submissions, essential
• Familiarity with CTMS and eTMF systems and confidence working with clinical research technologies.

🎁 Benefits

• Salary: CAD 76,000–95,000 per year.
• Work arrangement: Fully remote position within Canada.
• Employment: Full-time opportunity.
• Opportunity to contribute to clinical research and the advancement of new treatments.
• Collaborative, cross-functional working environment with opportunities to support process
• Exposure to study start-up activities across North America and a broad clinical research