Local Study Associate Director Oncology
Are you ready to make a difference with your expertise in a company that transforms scientific ideas into life-changing medicines? At AstraZeneca, we harness the potential of our people, encouraging you to exceed your expectations and achieve remarkable outcomes.
Join us at MIND (Milan), one of our vibrant sites, where collaboration and authenticity are key. As a global science-led biopharmaceutical company, we focus on improving patient health worldwide, fostering innovation to develop groundbreaking medicines. With an unparalleled product portfolio in Oncology, Respiratory, and Cardio-Renal Metabolic diseases, we invite you to lead Local Study Teams (LSTs) at the country level, delivering clinical studies with precision and compliance.
Are you inspired by science's possibilities? Discover what you can achieve with us!
Accountabilities
As the Local Study Associate Director, you will oversee clinical studies at the country level, ensuring successful execution from site identification to documentation archiving. Your leadership will drive operational management, compliance, and relationship management for high-quality study data delivery. Key responsibilities include:
- Leadership and Oversight: Lead Local Study Team (LST), optimize team performance, ensure compliance, organize meetings, and manage budgets.
- Study Management: Meet study commitments, develop monitoring plans, coordinate site selection, and ensure timely document submissions.
- Monitoring and Compliance: Perform co-monitoring visits, review reports, and oversee audit activities.
- Documentation and Systems: Ensure document completeness, maintain systems, and prepare for final archiving.
- Collaboration and Reporting: Work closely with CRAs, Investigators, Regulatory Affairs, and provide updates on progress.
- Training and Support: Train new team members and contribute to process improvements.
- Miscellaneous: Ensure compliance with company values and support regional initiatives.
Essential Skills/Experience
- University degree or equivalent, preferred in biological science or healthcare-related field
- Minimum 1 year-experience as Project Manager in Clinical Operations
- A previous experience as CRA
- Fluent knowledge of spoken and written English and Italian
- Excellent knowledge of international guidelines – ICH-GCP
- Good knowledge of relevant local regulations
- Good medical knowledge in Oncology Therapeutic Area
- Excellent knowledge in Clinical Operations and understanding of the Clinical Study Process
- Excellent knowledge/experience of the Monitoring Process
- Good understanding of the Study Drug Handling Process and Data Management Process
- Leadership capabilities
- Excellent project management and organizational skills
- Goals oriented
- Ability to manage several complex projects at the same time
- Domicile: Milan
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 we need 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.
AstraZeneca offers an environment where collaboration and learning are integral to our success. We work together across locations and therapy areas to share knowledge and unlock opportunities for personal and professional growth. Our innovative approach in Oncology Regulatory ensures rapid approvals, transforming breakthrough science into tangible value for patients. Here, you'll be empowered to take ownership of your work and thrive in a diverse and inclusive setting.
Ready to step up and make a difference? Apply now to join our dynamic team!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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