Clinical Project Manager - Oncology

Job Description

Are you ready to lead the charge in transforming cancer treatment? As an Oncology Local Study Associate Director, you'll spearhead Local Study Teams at the country level, ensuring the successful delivery of oncology clinical studies. Your leadership will be pivotal in navigating resources, budgets, and timelines while adhering to AstraZeneca's procedural documents, international guidelines like ICH-GCP, and local regulations. In addition to leading teams, you may also engage in site monitoring to support our flexible capacity model. Your role will be crucial in identifying sites, performing qualifications, and ensuring seamless study execution from initiation to closure.

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in four therapy areas – Oncology; Cardiovascular, Renal and Metabolism (CVRM); Respiratory & Immunology (R&I); and Rare Disease.

At AstraZeneca Australia, we have been working to deliver the best value to patients for more than 60 years, and we push the boundaries of science to deliver life-changing medicines.

What you’ll do

• Lead Local Study Teams consisting of Study Start-up Managers, Contract Managers, CRAs, and CSAs for assigned studies.
• Optimize team performance at the country level, ensuring compliance with AZ Procedural Documents, ICH-GCP, and local regulations.
• Drive site selection by identifying potential sites/investigators, conducting Site Quality Risk Assessments, and overseeing Site Qualification Visits.
• Ensure timely submission of applications/documents to EC/IRB and Regulatory Authorities throughout the study duration.
• Manage and coordinate monitoring activities from site activation to study closure in collaboration with Clinical Research Associate Director.
• Review or oversee monitoring visit reports and provide proactive advice on study-related matters.

Essential for the role

• Bachelor’s degree in relevant discipline
• Significant experience in Study Management within a pharmaceutical or clinical background
• Thorough knowledge of Patient Safety processes and local regulations

Desirable for the role

• Advanced degree within field
• Professional certification
• Clinical study delivery operational experience
• Project management experience

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next!

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

• 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?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Visit our website: www.astrazeneca.com.au

AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA) and as a Silver Tier Employer within the Australian Workplace Equality Index (AWEI). Visit our ANZ Careers Page - www.astrazeneca.com.au/careers.html to learn more about our commitment to fostering a flexible, diverse, and inclusive environment.

We recognise that any recruitment process may present challenges, if there is anything we can do to make our recruitment process more accessible for you, please let us know.

Date Posted

Closing Date

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.