Associate Director, Clinical Project Lead
7 days ago
Location: Mississauga, Canada
Job reference: R-199699
Date posted: 05/31/2024
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
**What You'll Do**:
Step into an exciting role as the Associate Director, Clinical Project Lead. Here, you'll lead Cross-Functional Clinical Sub-Teams, oversee study deliverables, manage timelines and budgets, and serve as the primary liaison between functional groups, investigator sites, and vendors. Your proactive management will ensure patient safety, data integrity, inspection readiness, and compliance. Depending on the project's scope, you may also be a member of the Core Team.
**The impact **you’ll** have**:
- ** Project Management**: Drive the planning, implementation, and execution of pivotal clinical trials. Oversee CROs and relevant study vendors, ensuring top-quality deliverables.
- ** CRO Management**: Manage CRO relationships, ensuring appropriate scope of work, oversight, and training
- ** Budgeting & Forecasting**: Plan, track, and forecast the Global Clinical Operations budget and timelines to support Clinical Development financial goals.
- ** Operational Execution**: Ensure operations align with Alexion SOPs, ICH Guidelines, and Good Clinical Practices (GCP) to guarantee data quality, integrity, and patient protection.
- ** Communication**: Share clinical studies performance data with management and scientific teams.
- ** Documentation**: Prepare and maintain required study and regulatory documents. Contribute to the development and approval of study documents.
- ** Continuous Improvement**: Conduct lessons learned exercises for continuous process improvement.
**Who you are**:
- ** Experience**: Over 10 years of clinical research experience, with at least 5 years leading the planning and execution of global clinical trials.
- ** Team Leadership**: Ability to lead cross-functional teams and manage CROs.
- ** Budgeting Skills**: Experience in developing study budgets, forecasting, and financial oversight.
- ** Education**:Bachelor’s degree or equivalent in clinical practice/health care, life sciences, or drug development.
**Preferred Qualifications**:
- ** Advanced Degree**: Master's, PhD, or MD degree desirable.
- ** PMP Certification**: Preferred.
At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.
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