Clinical Trial Project Manager at AstraZeneca

South Turramurra, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

22 Feb, 26

Salary

0.0

Posted On

24 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Project Coordination, Cell Therapy, Study Management, ICH-GCP, Patient Safety, Leadership, Stakeholder Management, Risk Management, Budget Management, Site Monitoring, Regulatory Submissions, Team Building, Communication, Feasibility Assessment, Clinical Trials

Industry

Pharmaceutical Manufacturing

Description

Do you have expertise in clinical research project coordination, and a passion for Cell Therapy? Would you like to apply your expertise to deliver critical components of clinical studies in this fast-moving and innovative area in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! 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. Within Oncology R&D, AstraZeneca, we are investing in our internal capabilities to help us realise our ambition to become leaders in the delivery of next-generation cellular therapies. Leveraging historical expertise in biologics engineering, gene editing and immunology across solid and haematological malignancies, we are uniquely positioned to develop cutting-edge technologies to advance cell therapies in cancer treatment. We are recruiting for new Site Monitoring and Management (SMM) team members based in Australia (Sydney or Melbourne) to support our clinical trials as we develop the next generation of cell therapies. What you’ll do As a Clinical Trial Project Manager, you'll spearhead Local Study Teams (LSTs) to deliver critical components of clinical studies, ensuring compliance with AZ Procedural Documents, international guidelines like ICH-GCP, and local regulations. You may also perform site monitoring to support our flexible capacity model. Your role will be pivotal in identifying sites, performing qualifications, and ensuring seamless study execution from initiation to closure. Key responsibilities: Lead country delivery: Own Australian study commitments—quality, timelines, and budget—ensuring data is delivered inspection-ready and on time. Build and guide LSTs: Lead CRAs/CSAs, optimise performance, coach new members, and drive patient recruitment strategies and site relationships. Run feasibility, start-up, and selection: Drive clinical/operational feasibility; identify and qualify sites; perform Site Quality Risk Assessments and Site Qualification Visits. Own submissions, documentation, and systems: Ensure timely EC/IRB and Regulatory Authority submissions; prepare MICF/site ICFs and trial essential docs; set up and maintain CTMS/eTMF and required local systems. Manage monitoring, risk, contracts, and budgets: Coordinate monitoring from activation to close-out; review/co-monitor as needed; develop risk plans; prepare fSMA/Master CSA; maintain accurate study budgets and payments. Assure compliance and partner broadly: Keep the eTMF inspection-ready; lead audit/inspection readiness; uphold AZ Code of Ethics and local policies; collaborate with Global Study Teams, Medical Affairs, and SMM leadership, aligning CRAs regionally to minimise travel and carbon footprint. Essential for the role Significant study management experience within pharmaceutical or clinical research settings. Strong knowledge of ICH-GCP, Patient Safety processes, and Australian local regulations. Proven leadership of local study teams and site-facing delivery across feasibility, start-up, conduct, and close-out. Operational ownership of submissions, contracts/budgets, CTMS/eTMF, and monitoring coordination. Risk-based mindset with the ability to anticipate issues and drive timely resolution. Stakeholder excellence: Clear communicator who builds trust with investigators, vendors, and global stakeholders. Bachelor’s degree in a relevant discipline. Desirable for the role Advanced degree within the field. Professional certification (e.g., project management, GCP). Clinical study delivery operational experience across complex, multi-site trials – with cell therapy experience preferred. Project management experience with demonstrable outcomes. 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 Gold 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 via this Form Date Posted 25-Nov-2025 Closing Date 14-Dec-2025 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

As a Clinical Trial Project Manager, you'll lead Local Study Teams to ensure compliance with procedural documents and international guidelines while managing the execution of clinical studies. Your role will involve site identification, qualifications, and overseeing study execution from initiation to closure.