Study Contract Manager CAR-T

Are you ready to make a significant impact in the world of cell therapy? At AstraZeneca, we are committed to transforming the lives of patients by exploring innovative scientific solutions. As part of our Oncology R&D team, the Study Contract Manager plays a crucial role in driving costings and contracts, ensuring ethical, fair, and compliant practices. You'll be responsible for negotiating and budgeting in clinical trials, developing and managing contracts and annexes with investigators, institutions, or external vendors. Regular communication with key stakeholders, both internal and external, will be part of your daily routine. Depending on your experience level, you might hold different internal titles such as SCM or Senior SCM, which are determined by your years of experience, performance record, and ability to mentor junior colleagues.

• 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 agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources.
• 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.

Upon local decision, additional responsibilities may include:

• Training and mentoring of new members of the local Study Team regarding financial/contractual issues and sharing experiences.
• Support preparation and negotiation of a Local Master Service Agreement.
• Contribute to process improvements, knowledge transfer, and best practice sharing.

• 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.

• 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 computer skills 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.

AstraZeneca offers an environment where innovation thrives. We are dedicated to fundamentally changing cancer treatment by focusing on outcomes rather than just medicines. Our commitment to early diagnosis and survivorship ensures no patient is left behind. With a game-changing pipeline backed by science, we are pioneering new treatment pathways using digital innovations. Join us in shaping the cancer care environment and transforming patient experiences worldwide.

Ready to make a difference? Apply now to be part of a team that is confident cures for cancer are within reach!

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.