Clinical Research Specialist (Sponsor Perspective)

Your Mission

Reporting to the Director of Clinical Operations, you will be at the heart of coordinating clinical trials for Lallemand Health Solutions. You will ensure scientific rigor, ethical compliance, and regulatory adherence, contributing to innovation in probiotic health.

Key Responsibilities

• Oversee clinical trials within the LHS portfolio
• Manage project budgets and resources
• Draft and revise protocols, ICFs, CRFs, statistical plans
• Prepare regulatory and ethics submissions (IRB, agencies)
• Provide administrative support (contracts, grants)
• Coordinate investigational product (IP) supply and logistics
• Evaluate CROs, investigator sites, universities, and PIs
• Conduct ongoing monitoring (SIVs, MVs, COVs, monthly reports)
• Write monitoring reports and follow up on corrective actions
• Coordinate clinical sample analysis
• Participate in data analysis and reporting
• Draft study reports and manuscripts for publication
• Present findings at scientific meetings or congresses
• Maintain and update clinical operations documentation
• Support other project management tasks as assigned

Profile Sought

• Master's degree in science or diploma in clinical research
• Minimum 3 years of experience in clinical research
• Knowledge of GCP and clinical trial regulations in Canada and the U.S.
• Strong scientific writing and communication skills in English and French
• Detail-oriented, autonomous, and rigorous
• Excellent project management and critical thinking skills

Employment Conditions

• Flexible schedule: 37.5 hours/week (Monday to Friday)
• Partial remote work possible
• Salary based on experience
• Group insurance plan and registered pension plan