Study Contracts Manager

About the Company

Responsibilities

• ● Study Contracts Manager Introduction to role: Are you ready to play a pivotal role in the world of clinical trials As a Study Contracts Manager, you'll be at the forefront of negotiating and budgeting, ensuring ethical and compliant practices in developing and managing contracts with investigators, institutions, and external vendors. Your expertise will drive costings and contracts, making a significant impact on the success of clinical studies. Regular communication with key stakeholders will be your forte as you navigate the complexities of clinical trial agreements. This position serves as a flexible contracting and budgeting resource, providing coverage across studies and teams based on business needs, workload balancing, and organizational priorities.
• ● 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 .
• ● Additional responsibilities may include training and mentoring new members of the local Study Team regarding financial/contractual issues and sharing experiences, supporting preparation and negotiation of a Local Master Service Agreement, and contributing to process improvements, knowledge transfer, and best practice sharing. Essential Skills/Experience:
• ● Bachelor's degree required in related discipline with 4 + years of experience negotiating industry contracts such as Clinical Study Agreements, CDAs , and amendments for site, SMO, CRO, or Sponsor .
• ● Ability to support multiple studies and agreement types, adapting quickly to changing business needs and priorities
• ● Provide flexible contracting and budgeting support across multiple studies, including negotiation of CSAs, CDAs , amendments, and budgets creation
• ● 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.