Study Contracts Associate Director

Job Description

Are you ready to lead and innovate in the world of clinical study agreements? As a Study Contracts Associate Director, you'll be critical for developing site partnerships and at the forefront of ensuring ethical, fair, and compliant practices in developing, negotiating, and executing clinical agreements and investigator budgets across Australia and New Zealand. You'll provide leadership and guidance driving process improvements and managing stakeholder relationships. This pivotal role serves as the central point for escalation of legal, contract language, and budget issues. Are you prepared to make a significant impact?

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.

Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world’s most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world.

What you’ll do

• Drive a consistent and effective operating model to standardize Clinical Study Agreements (CSAs) and Budget
• Demonstrate accurate knowledge of regulations and policies in order to be able to maintain and develop the effectiveness of Clinical Study Agreements
• Demonstrate a strong understanding of how the contracting process and budget contributes to Project Management practices (schedule/cost forecasting and risk management)
• Act as point of contact and interface with Legal if necessary to ensure integrity of contracts
• Support contracting activities to ensure compliance to AZ’s policies including FMV principles
• Outlines and train the AZ team on all components of a Clinical Study Agreement to quality, budget, project standards, and company quality standards
• Support additional start-up activities when required, including HREC and RGO submissions.

This is an initial 12-month maximum term contract role based in Sydney.

Essential for the role

• Bachelor degree required, preferably in life science, law, finance or equivalent qualification or experience.

• Five or more years of experience in the pharmaceutical industry working with delivery of clinical studies

• Good knowledge of relevant local regulations

• Good collaboration, negotiation and interpersonal skills

• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.

• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

Desirable for the role

• Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
• Good analytical, problem-solving and conflict resolution skills.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with respect to start-up activities, specifically contract negotiation
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
• Demonstrates ability to set and manage priorities, resources, performance targets and project initiatives

Why AstraZeneca?

At AstraZeneca, we are driven by a shared belief in the power of science to redefine what's possible. Our commitment to making a difference fuels our passion for innovation as we work towards treating, preventing, modifying, and even curing some of the world's most complex diseases. We embrace curiosity and courage, empowering our teams to explore new frontiers without fear of failure. By integrating digital, data science, and AI, we fast-forward our research to make a real impact on patients' lives globally. Join us in an inclusive environment where collaboration thrives, drawing on diverse global knowledge to create swift impacts on disease.

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.