About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Digital Health R&D’s ambition is to transform healthcare, powered by digital, science and partnerships, to deliver the healthcare outcomes and experience that patients care about the most. Now we are further accelerating our transformation efforts to ensure we demonstrate the best in new technology and ground-breaking capabilities to keep us at the forefront of future drug development.

Overview of Business Unit

Digital Health (DH) R&D is reimagining how we work to position AstraZeneca as an industry leader, making the development & delivery of new medicines easier. We’re doing this by harnessing the latest innovations enabled by digital, data & analytics and working with our people to craft and build the technology and working practices.

The Digital Study Associate Director role sits within the DH R&D Oncology Clinical and Business Delivery team which is accountable for executing clinical research and studies to deliver clinical data to support digital product development.

About the role :

This role will provide Study Leadership throughout the development and testing of Oncology Digital Products with a focus on testing, scaling and deployment into clinics, serving as a key contact for internal and external facing stakeholders.

What you’ll do:

• Be the Clinical Operations Lead for pilot/Clinical Study activities specifically designed to test DH Onc designed digital solutions
• Acts as a contact supporting the execution of clinical research with external academic and/or healthcare partner institutions,
• Responsible for leading a cross-functional study team to enable successful delivery of clinical studies from the onset of study specifications through to study archiving
• Mentor and empower a cross-functional team to operationally deliver defined clinical studies or assigned clinical project activities to time, cost and appropriate quality in line with ICH/GCP and AZ relevant SOPs
• Be the key point of contact to the CRO project manager if applicable to ensure delivery to time, quality and cost; ensuring AZ oversight of the CRO is defined and performed across relevant AZ functions for outsourced studies
• Develop and maintain up to date study plans, ensure study level performance against agreed upon plans, lead proactive risk and contingency planning and raise issues as appropriate
• Provide input and hold accountability for the development of crucial study level documents (i.e. Clinical study Protocol)
• Select and lead vendors, handling their performance to ensure high quality, timely delivered services
• Ensure appropriate training is provided to the local teams, investigators and site staff as well as vendor teams as needed; taking an active role in the Investigators/Monitoring Meetings
• Set initial operational study budget with the DH Oncology Product team, and are responsible for study budget throughout the study, providing budget progress reports to leadership
• Ensure studies are inspection-ready at all times, according to ICH-GCP, AZ SOP and relevant policies/guidelines
• Responsible for the completeness of the Trial Master File; being the primary Study Management point-of-contact in the event of an audit or inspection
• May be assigned responsibility for leadership or participation in project work including applying process improvements methods and to inspire change for new ways to work
• You are responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and procedures
• Assist with IRB submissions, amendments, and continuing reviews

Essentials for the role:

• University degree (or equivalent), preferably in medical or biological sciences or related to clinical research. Advanced degree is preferred.
• Relevant experience in the pharmaceutical industry, or a similar organization (e.g. CRO) including clinical trial leadership experience (preferably on global trials)
• Solid understanding of clinical operations and study management processes
• Clinical project management experience. PMP certification is desirable.
• Possess strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, empowering critical thinking, problem solving, and influencing
• Significant experience managing study budgets
• Strong communication skills with the ability to build positive relationships, including vendor leadership skills
• Highly efficient: able to navigate ambiguity and solve problems in a fast-paced environment; able to influence without authority

Desirable:

• Oncology experience
• Experience working at a healthcare site
• Knowledge in digital health applications
• Experienced in the implementation of quantitative and qualitative evidence

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Competitive Salary and Benefits