Study Contract Manager, Cell Therapy

Study Contract Manager, Cell Therapy

The Study Contract Manager (SCM) plays a crucial role in driving costings and contracts, being responsible for negotiation and budgeting in clinical trials. You will develop and manage contracts and annexes with investigators, institutions, or external vendors, ensuring ethical, fair, and compliant practices. Regular communication with investigators, institutions, and other key stakeholders is essential. Depending on your experience level, you may hold different internal titles such as SCM or Senior SCM.

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 a point of contact and interface with Legal if necessary to ensure the 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 completed 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 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.

Essential Skills/Experience:

• Bachelor's degree, preferably in a related field: life science, law,or finance.
• 2+ years of relevant experience
• 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 detail.
• Good written and verbal communication skills.
• Good collaboration and interpersonal skills.
• Good negotiation skills.

Desirable Skills/Experience:

• Experince in cell therapy highly preferrred
• Oncology & hematology experince preferred
• Ability to work in an environment of remote collaborators.
• Post-graduate training in contracts administration or work experience as a paralegal in the pharmaceutical or healthcare industry.
• Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and contribute 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 handle 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.

At AstraZeneca, we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We thrive in our inclusive, diverse, and bold environment where we draw on our diverse knowledge to take smart risks and uncover new ways to deliver better for our patients. Our rich pipeline provides exposure to the complete drug delivery process and opportunities to take on new challenges.

Ready to make a difference? Apply now!

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.