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JOB DESCRIPTION

The Senior Director, Cell Therapy Study Management (Sr CT SM), is responsible for developing strategy and tactics to deliver studies within Cell Therapy Clinical Operations (CTCO) in the consistent and efficient way, and ensuring knowledge sharing and upskilling across Study Management resources allocated to the projects within Cell Therapy.
This role combines deep Cell Therapy Operations knowledge, strong leadership and excellent partner management to lead a large, multi geography team of Cell Therapy Study Management professionals, ensuring consistency and efficiency for multiple ongoing Clinical Studies. The individual will develop a strategy to ensure alignment across this team, to ensure CTCO studies deliver to agreed Resources, budget and timelines.
The role will partner closely with Cell Therapy collaborators across CTCO and AZ more broadly.
The Sr CT SM will line manage the Director, Study Management (DSM) and subsequent Study management team members (Global Study Associate Director, Global Study Manager and Global Study Associate) across CTCO across multiple geographies.
They will drives consistency and efficiency across CTCO Teams, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.

ACCOUNTABLE FOR LEADING THE STUDY MANAGEMENT TEAM

• Leadership of dedicated group, building the team spirit, developing team style and behaviour.
• Working in close collaboration with SrGPD and DSM accountable for timely, within budget and high-quality delivery of the studies from Study Hand-over to Clinical Study Report
• Accountable for resources and capacity planning, allocation and utilization for the group.
• Accountable for performance, training and development for the group.
• Ensure right level of Cell Therapy and knowledge sharing and consistent ways of working across Study Management teams
• Act as study management main point of contact for SrGPD and other partners within Cell Therapy to ensure Study Management has a good understanding of the priorities, is aligned strategically and has a shared vision with project management. Additionally, this role will share their insights with the project team (SrGPD)
• Contributes to efficient CTCO organization by working closely with Cell Therapy Program Management teams, Strategic Partnerships & Patients Operations and Business Processes, Quality and Learning

ACCOUNTABLE FOR SUPPORT FUNCTIONS TO THE PROGRAM MANAGEMENT TEAMS

• Drive Inspection Readiness across studies execution, jointly with the BPCL group, with high standards, tailored to Cell Therapy requirements
• Ensure completeness and timeliness of the eTMF to maintain it “Inspection Ready”.
• Accountable for systems and processes set-up/maintenance/updates to support Cell Therapy Program Management Teams in forecasting study timelines, resources, recruitment, study materials and drugs.
• Maintains and facilitates interactions with internal functions (including but not limited to Data Management, Procurement, Regulatory), and external functions (including the CROs and other external service providers) to ensure an efficient study delivery to time, costs and quality objectives.
• Lead the group supporting Program Management Teams with budget management, such as external service provider invoice reconciliation.
• Lead the group supporting Program Management in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study
• Lead the group in charge of planning and conduct of internal and external meetings (e.g. Investigators’/Monitors’ meeting).
• Drive an environment of global standardization and continuous improvement, jointly with the BPCL group
• Ensures collaboration/support to Cell Therapy Sites Partnerships & Patients Operations, other functions in CTCO and ClinOps functions at AstraZeneca
• Ensures that study activities align with local policies and code of ethics.

ACCOUNTABLE FOR MAINTAINING DASHBOARDS AND METRICS FOR PROGRAM DELIVERY SUPPORT FUNCTIONS TO THE PROGRAM MANAGEMENT TEAMS

• Support Program Management, Srategic Partnerships & Patients Operations Teams and Business Processes, Quality and Learning, with reports and performance dashboards
• Ensures relevant systems are continuously improved and updated to follow program and studies execution delivery.
• Sponsor Cell Therapy Clinical Operations non-drug strategy & organizational infrastructures
• Contribute to the development and maintenance of delivery models provided by Cell Therapy Clinical Operations, balancing partners needs and efficiency
• Deliver agreed activities within functional budget target including management of FTEs
• A catalyst for cross-functional improvements and driving organizational change