National EH&S Director leading safety, environmental compliance, and risk programs for GESI’s Canadian operations. Standardizing enterprise systems across hazardous industrial, waste, and refinery sites.
About the role
- Clinical research director leading AstraZeneca’s Ontario site management and monitoring operations. Managing clinical study delivery, teams, budgets, compliance, and site oversight.
Responsibilities
- Deliver the committed part of all supervised clinical interventional studies according to resources, budget, timelines, AZ Procedural Documents, ICH-GCP, and local regulations
- Line manage dedicated staff groups and plan and utilize staff resources and assigned budgets
- Set objectives and follow up on performance
- Contribute to regional and global work tasks as delegated
- Ensure study sites are identified, qualified, set up, initiated, supervised, closed, and archived
- Lead dedicated groups and build team spirit, team style, and behaviour
- Ensure adequate study resources and appropriate workloads
- Develop and performance-manage direct reports
- Ensure direct reports have development and training plans
- Coach direct reports and coordinate external coaching when needed
- Prepare salary and bonus proposals for direct reports with leadership and HR
- Contribute to efficient country-level SMM organization and functioning
- Contribute to feasibility work and quality improvement of study processes
- Supervise country-level study delivery targets for speed and quality
- Keep all systems updated and ensure the eTMF remains inspection-ready
- Assist with forecasting study timelines, resources, recruitment, materials, and drugs
- Direct LSAD/Local Study Teams on major study commitments and resolve key issues
- Support regional SMM initiatives and collaborate with Medical Affairs
- Ensure study activities align with local policies and codes of ethics
- Review SQV reports and accompanied/co-monitoring/training/QC visits
- Perform accompanied site visits according to local QC plans
Requirements
- Bachelor degree in related subject area, preferably in life science, or equivalent qualification
- Proficiency in both spoken and written French is a requirement if in Quebec
- Minimum 5 years of experience in Development Operations (CRA / SrCRA / LSAD) or other related fields
- Excellent interpersonal skills
- Ability to manage change with a positive approach
- Proven project management experience
- Excellent organisational, analytical, influencing and negotiation skills
- Excellent presentation and communication skills, verbal and written
- Line management experience
- Very good knowledge of the Clinical Study Process and international ICH-GCP guidelines
- Excellent knowledge of the Monitoring Process
- Good understanding of the Study Drug Handling Process and the Data Management Process
- Good knowledge of relevant local and international regulations
- Good medical knowledge and ability to learn relevant therapeutic areas
- Ability to deliver quality according to requested standards
- Ability to identify and champion efficient and effective methods/processes for delivering quality clinical trials with reduced budget and time
- Ability to learn and adapt to IT systems
- Ability for national and international travel
Benefits
- Annual Variable Pay Bonus/Short Term Incentive opportunity
- Eligibility to participate in equity-based long-term incentive program (if applicable to role)
- Competitive Flex Benefits & Retirement Savings Program
- 4 weeks’ paid vacation
- Annual Personal Days
- Contract Benefits Program for Fixed Term Contract/Temporary positions (excluding students)
- Accommodation available on request for persons with disabilities
- Diversity and inclusion commitment
- AI used as part of the recruitment process
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