Study Contract Manager

Job Title: Study Contract Manager

Introduction to role:
Are you ready to play a pivotal role in the world of clinical trials? As a Study Contract Manager, you'll be at the forefront of negotiating and budgeting, ensuring ethical and compliant practices in contracts with investigators, institutions, and external vendors. Your expertise will drive the costings and contracts that are crucial for successful clinical trials. Regular communication with key stakeholders will be a part of your daily routine, making you an essential link in the chain of clinical research.

Accountabilities:

• Adapt global templates of agreements to local use in accordance with local requirements and SOPs.

• Develop and negotiate clinical site budgets based on Fair Market Value.

• Negotiate agreement language and budget with clinical study sites.

• Act as point of contact and interface with Legal if necessary to ensure integrity of contracts.

• Maintain the status of agreements, budgets, issues, payments, amendments, and communications for the duration of the study.

• Ensure final contract documents are consistent with agreements reached at negotiations.

• Ensure all agreements are executed in a timely manner contributing to efficient site start-up timelines.

• Support internal and external audit activities.

• Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, and security.

• Ensure that all contracts are included in the TMF.

Essential Skills/Experience:

• Bachelor degree in related discipline, preferably in life science, law, finance or equivalent qualification.

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

• Good knowledge of relevant local regulations.

• Basic understanding of the drug development process.

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

• Excellent attention to details.

• Good written and verbal communication skills.

• Good collaboration and interpersonal skills.

• Good negotiation skills.

Desirable Skills/Experience:

• Ability to work in an environment of remote collaborators.

• Post-graduate training in contracts administration or work experience as a paralegal in pharmaceutical or health care industry.

• 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.

• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

• Good analytical and problem-solving skills.

• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.

• Familiar with risk-based monitoring approach including remote monitoring.

• Good cultural awareness.

• Ability to understand the impact of technology on projects and to use and develop digital literacy while making appropriate use of systems/software in an e-enabled environment.

• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.

At AstraZeneca, we are driven by a bold vision to eliminate cancer as a cause of death. Our team is dedicated to pioneering new frontiers in oncology research, fusing cutting-edge science with the latest technology. With a collaborative spirit, we unite academia and industry to expedite research in some of the hardest-to-treat cancers. Empowered at every level, we make fearless decisions that prioritize patient outcomes. Join us in our mission to improve the lives of millions with cancer.

Ready to make an impact? Apply now and be part of our journey!

Where can I find out more?

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

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Date Posted

18-Jul-2025

Closing Date

26-Jul-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

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 authorisation and employment eligibility verification requirements.