Director, Site Management & Monitoring
AstraZeneca
AstraZeneca seeks a Director of Site Management & Monitoring to oversee clinical trial delivery across assigned studies in Quebec. This leadership role involves managing site operations, supervising staff, ensuring regulatory compliance, and maintaining study timelines and budgets.
Responsibilities
- Lead and develop dedicated staff groups; manage workload and performance reviews
- Oversee site qualification, setup, initiation, supervision, and closure activities
- Ensure study delivery to plan with quality, speed, and adherence to budgets
- Conduct and review site visits, monitoring activities, and quality control assessments
- Maintain regulatory compliance and keep electronic Trial Master File inspection-ready
Requirements
- Bachelor's degree in life science or equivalent qualification
- Minimum 5 years in clinical development operations, CRA, or related roles
- Fluency in spoken and written French
- Line management experience with proven team leadership
- Strong knowledge of ICH-GCP guidelines and clinical monitoring processes
- Project management expertise with excellent communication skills
- Good understanding of study drug handling and data management processes
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