Study Contract Manager

Jobinhalt

The Study Contract Manager (SCM) play an important role in driving the costings and contracts being responsible for negotiation and budgeting in clinical trials and for developing and managing contracts and annexes with investigators and institutions or external vendors ensuring ethical, fair and compliant practices.

SCM has regular communication with investigators and institutions as well as other key external and internal stakeholders.

SCM might have different internal titles based on the experience level (SCM, Senior SCM). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head or Executive Director, Regional Head).

Typical 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.
• For each agreement 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.
• Note: Additional responsibilities may be adjusted locally.
  
  

Qualification

• 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.