Introduction to role:
Are you ready to push the boundaries of science and transform the lives of patients living with cancer? At AstraZeneca's Cell Therapy division, we are committed to making a difference by exploring and innovating in the field of oncology. Our passion for science drives us to treat, prevent, modify, and even cure some of the world's most complex diseases. As part of our Oncology R&D team, you will support clinical and commercial production across multiple sites, fusing data and technology with scientific innovations to achieve groundbreaking results.
Join us in crafting a collaborative culture that champions knowledge-sharing and ambitious thinking, providing you with opportunities to work across teams, functions, and even the globe.
Accountabilities:
As the Global Study Manager, you will be a key member of the extended global study team supporting the Cell Therapy department. Your role will involve delivering clinical studies to time, cost, and quality from Clinical Study Protocol (CSP) development through to study archiving. Reporting to the Clinical Program Director, you will:
- Work cross-functionally to build partnerships with internal and external partners for successful study delivery.
- Maintain interactions with internal functions like Data Management, Procurement, Regulatory, Patient Safety, and Quality Assurance, as well as external functions such as CROs and other service providers.
- Lead or participate in preparing study documents and external service provider-related documents.
- Support the Global Study Associate Director (GSAD) in project management.
- Ensure supply of study materials and Investigational product by liaising with Clinical Supply Chain or external service providers.
- Assist with budget management, including external service provider invoice reconciliation.
- Ensure studies are inspection-ready at all times according to ICH-GCP, AZ SOP, and relevant policies/guidelines.
- Verify quality of study documents in the Trial Master File.
- Assist with planning and conducting internal and external meetings.
- Monitor study conduct and progress, resolving risks and issues impacting study delivery.
- Contribute to team productivity by facilitating positive team dynamics.
- Provide input into non-drug project work including training activities and procedure development.
- Be responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and SOPs.
Essential Skills/Experience
- Bachelor's degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
- Minimum 5 years' experience within the pharmaceutical industry supporting clinical operations.
- Project management, organizational, and analytical skills.
- Knowledge of clinical development/drug development process across various phases and therapy areas as well as relevant knowledge of international guidelines ICG-GCP.
- Previous Cell Therapy experience is a plus.
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.
At AstraZeneca, we are empowered to act fast on smart risks and keep ahead in the fast-paced Oncology field. Our pioneering spirit drives us to make bold moves that transform cancer treatment and improve patient outcomes. With one of the broadest Oncology pipelines in the industry, you'll have opportunities to work with novel drugs and discover what's next. We foster a mindset of courage where everyone is empowered to innovate and work at pace. Collaborate globally with top experts and diverse functions to solve varied and interesting problems. Our commitment to patients is embedded in our values, making a meaningful difference worldwide.
Ready to make an impact? Apply now and join us on this exciting journey!
