Local Study Associate Director, Feasibility Lead Italy

Introduction to role:

The Local Study Associate Director, Feasibility Lead
for Spain and Italy is a key part of the country Cell Therapy Site Management & Monitoring (SMM) organisation. This role supports the feasibility assessment and delivery of the early and late-development Cell Therapy Portfolio within the country, providing end-to-end oversight of feasibility activities for AstraZeneca internally delivered studies.

The role is responsible for leading Local Study Team(s) (LSTs) at the country level to deliver committed components of clinical studies according to agreed resources, budget, and timelines, ensuring compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations.

This role requires significant experience and knowledge in developing local recruitment and retention Feasibility Strategies(s) (LSTs) at the country level to deliver committed components of clinical studies according to agreed resources, budget, and timelines, ensuring compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. It requires significant experience and knowledge in developing local recruitment and retention Feasibility Strategies, balanced with strong project management capabilities, strategic thinking, data analytics/interpretation, and technical skills as well as a good understanding of country landscape and priorities.

In addition to feasibility responsibilities, the LSAD – Feasibility may be requested to undertake local study leadership activities at country level, supporting the delivery of clinical studies within agreed resources, budget, and timelines, and in compliance with AZ procedural documents, international guidelines (e.g., ICH-GCP), and local regulations. These activities may span site identification, qualification, set-up, initiation, monitoring oversight, and closure.

• Accountable to Senior Director Feasibility Cell Therapy who sets the Feasibility Strategy Globally from design feasibility through operational feasibility and study baseline/re-baseline.
• Responsible for leading end to end activities for Spain and Italy and acting as single point of contact for all stages of the local feasibility assessment operations ensuring actionable feedback for their country that enables optimal study design, site selection, manging right country/site allocation, and recruitment forecast baseline for start-up.
• Serve as Subject Matter Expert for feasibility and recruitment in the country, and expert user for study design and planning digital platforms, including oversight and training of SMM country’s users (LSADs, S/DSMM).

Typical activities include but not exhaustive:

• Contribute to the design remit and study specification validation by identifying country-specific challenges
• Identify any conflicts with clinical standard of care, provide transparency on key delivery challenges identified by investigator feasibility responses and targeted competitive landscape and trends discussions with Medical Affairs
• Leverage AstraZeneca/competitor performance data to build realistic, cost-efficient sustainable recruitment targets and strategies, provide early transparency on recruitment strategies (ie, utilization of recruitment or site identification vendors, site-specific recruitment tools, etc.).
• Creating feedback for country in collaboration with the SMM Leadership Team and other key stakeholders (Site Partnerships or Field Clinical Advisers as applicable and/or Medical Affairs) and discussing critical points directly with Global Feasibility and the Global Project Team
• Identify, follow-up and share with country SMM Leadership Team (LT) early pipeline information or project updates to allow early country planning and frontloading SMM input.
• Manage, validate and deliver the country SMM feasibility responses for internal studies on time, with quality, to meet study planned LSI milestone, Patient Recruitment Framework recommendations and any other Global Medicines Development patient recruitment objectives
• Lead the development of robust country-specific and site-specific recruitment and retention…