Your Key Responsibilities :

Your responsibilities include, but not limited to:

• Oversees clinical study activities with Sandoz Development Centers, third parties and CROs to ensure that GCPs and Sandoz requirements are followed.
• Ensure that essential documentation is received according to set timelines to support clinical trial activities.
• Provide feedback on clinical study protocols and study designs. Represents sponsor for on-site monitoring at clinical trial sites when applicable. Ensures that the monitoring reports are accurate and that study report is suitable for submission to Health Canada.
• Prepare recommendations on clinical strategies for all projects involving clinical components.
• Support clinical due diligence activities for local and global business development evaluations.
• Prepare Scientific Advice packages submitted to Health Canada.
• Responsible for the evaluation of Access to Information requests and oversees activities related to the Public Release of Clinical Information.

What you’ll bring to the role :

ESSENTIAL REQUIREMENTS:

• Bachelor in pharmacy, pharmacology, biochemistry, etc.
• 5 to 8 years of experience as clinical project manager/clinical research associate.
• In-depth knowledge of current clinical Canadian guidelines and good knowledge of EU and US clinical requirements.
• Strong knowledge and understanding of GCP related requirements, clinical design and strategy.
• Fluency in oral and written French is mandatory. Due to the nature of our operations, oral and written fluency in English is required for regular communication with customers, partners, and/or colleagues, whether in Canada or internationally.
• Very good analytical thinking skills.
• Ability to manage multiple projects and priorities.
• Sense of organization and autonomy.

You’ll receive :

• A minimum of three weeks’ vacation.
• Paid time off in addition to your annual vacation and statutory holidays.
• Time back between Christmas and New Year’s Day with full pay.
• Generous and flexible group insurance coverage through our private plan.
• Employee and family assistance.
• Hybrid work formula offered.
• Telemedicine services.
• Career enhancement and development, including learning, training and professional recognition opportunities.

Sandoz Canada is proudly certified as a Great Place to Work™!
Learn more about the certification .

• Oversees clinical study activities with Sandoz Development Centers, third parties and CROs to ensure that GCPs and Sandoz requirements are followed.
• Ensure that essential documentation is received according to set timelines to support clinical trial activities.
• Provide feedback on clinical study protocols and study designs. Represents sponsor for on-site monitoring at clinical trial sites when applicable. Ensures that the monitoring reports are accurate and that study report is suitable for submission to Health Canada.
• Prepare recommendations on clinical strategies for all projects involving clinical components.
• Support clinical due diligence activities for local and global business development evaluations.
• Prepare Scientific Advice packages submitted to Health Canada.
• Responsible for the evaluation of Access to Information requests and oversees activities related to the Public Release of Clinical Information