Sr Director Cell Therapy Study Management

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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 ICHGCP as well as relevant local regulations.

Typical Accountabilities

• 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 highquality delivery of the studies from Study Handover 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 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 setup/maintenance/updates to support Cell Therapy Program Management Teams in forecasting study timelines resources recruitment study materials and .
• 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 delivery.
• Sponsor Cell Therapy Clinical Operations nondrug 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 crossfunctional improvements and driving organizational change

Education Qualifications Skills and Experience

Essential:

• Bachelors of Science in an appropriate subject area
• Extensive experience in Study Management within a pharmaceutical or clinical background
• Thorough knowledge of Study Management processes
• Excellent communication and relationship building skills
• Extensive knowledge of clinical and pharmaceutical drug development process
• Proven line management and leadership expertise
• Demonstrated development of others identifying and providing opportunities to improve the capabilities of other people
• Demonstrated ability to set and manage priorities resources performance targets and project initiatives in a global environment
• Cultural Awareness: Is aware of and sensitive to cultural differences and their impact on communication expectations and performance.
• Experience in leading teams both locally and internationally.

Desirable

• Advanced degree in a scientific subject area
• Expert reputation within the business and industry
• Extensive knowledge of the latest technical and regulatory expectations

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AstraZenecais an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment assessment and selection process and may be requested by emailing.

Date Posted