Study Contracts Manager - Cell Therapy at AstraZeneca
South Turramurra, New South Wales, Australia -
Full Time


Start Date

Immediate

Expiry Date

14 Sep, 26

Salary

0.0

Posted On

16 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Clinical Trial Contracting, Budget Negotiation, Fair Market Value, ICH-GCP, Regulatory Compliance, Clinical Site Management, Contract Administration, Stakeholder Management, Audit Readiness, Process Improvement, Analytical Skills, Written And Verbal Communication

Industry

Pharmaceutical Manufacturing

Description
Do you have extensive study contracts experience and sharp negotiation skills? Use them to speed up study start-up and accelerate therapy delivery for people living with serious disease. If you would like to apply your expertise 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 worked for more than 60 years to deliver the best value to patients. We advance the frontiers of science to develop life-changing medicines. Operating as part of a new, fast‑growing global cell therapy organisation, we are building the frameworks, networks and capabilities needed to accelerate novel, complex therapies to patients. What you’ll do The Study Contract Manager at AstraZeneca plays a meaningful role in negotiating and budgeting clinical trials. You'll develop and manage contracts with investigators, institutions, or external vendors while ensuring integrity, fairness, and regulatory compliance. Reporting to the regional Study Start Up Director, this role is based in Sydney with hybrid working (in the office 3 days/week). Key Responsibilities: Lead clinical site contracts and budgets: adapt global agreement templates to local requirements and SOPs, ensuring ethical, fair and compliant practices. Negotiate with study sites: own budget development using Fair Market Value, and negotiate agreement language and financial terms with investigators and institutions. Drive timely site start-up: track and manage agreement status, amendments, payments and issues to enable efficient execution and inclusion in the TMF. Partner with Legal and stakeholders: act as the point of contact with Legal to safeguard contract integrity; collaborate with study teams and external partners. Support audit readiness: maintain compliant documentation and contribute to internal and external audits across studies. Champion improvements: contribute to process enhancements, knowledge sharing, and mentoring of colleagues on financial/contractual practices and support preparation and negotiation of a local Master Service Agreement. Essential for the role: Bachelor’s degree in life science, law, finance, or equivalent qualification. Strong knowledge of ICH-GCP and relevant local regulations; basic GMP/GDP awareness. Extensive clinical trial contracting expertise (5-7 years) with demonstrable negotiation skills and FMV-based budget development within pharmaceutical (preferred) or CRO environments. Understanding of clinical study management in complex therapeutic areas (eg oncology), including monitoring, study drug handling and data management. Process improvement mindset with strong analytical and problem-solving skills; ability to manage multiple deadlines. Meticulous attention to detail with effective written and verbal communication and collaboration skills. Ability to travel nationally as required. Desirable: Experience in remote collaboration across dispersed teams and stakeholders. Post-graduate training in contracts administration or paralegal experience in pharma/healthcare. Familiarity with risk-based monitoring and good cultural awareness in international studies. Tech-savvy with ability to use e-enabled systems/software in clinical operations. Therapeutic area knowledge and ability to learn relevant AstraZeneca therapeutic areas. 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. Guidance on AI use: We support you using AI tools responsibly in the recruitment process to help you be at your best and showcase your knowledge, skills and abilities. Review our guide crafted to assist you: https://careers.astrazeneca.com/aiguidance Where can I find out more? Visit our Global Website - https://www.astrazeneca.com/ Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ Follow us on Instagram – https://www.instragram.com/astrazeneca/ 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 16-June-2026 Closing Date 16-July-2026 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
Lead the negotiation and budgeting of clinical site contracts and budgets while ensuring regulatory compliance and ethical practices. Drive timely site start-up by managing agreement status, amendments, and collaborating with legal and study teams.
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