Local Study Associate Director

Typical Accountabilities:
• As a regional technical expert develops and maintains or project manages the study management process and technology required in clinical trials

• Acts as a source of knowledge in area of expertise, defining and communicating important initiatives across departments and functions

• As a project manager plans and leads the delivery of all components of a clinical study to time, quality, budget, project standards, company quality standards, and scientific requirements from the study design team

• As a project manager leads preparation and delivery of study documents

• As an expert accountable for specialised research or delivery of internal reports to enhance the effectiveness of study management contributions to worldwide submissions across a range of products

• Applies expert statistical skills to support internal proposal development and external regulatory submissions

• Keeps own knowledge of best practices and new relevant developments up to date

• Leads and implements globally agreed study delivery and Clinical Development strategies including process and technology related to Study Delivery


Typical People Management Responsibility (direct / indirect reports):
• Approximate number of people managed in total (all levels) - 10
• Matrix Manager – (projects/dotted line)

What is the global remit? (how many countries will the role operate in?):
• Own country

Education, Qualifications, Skills and Experience:
• Essential: Bachelor’s degree in relevant discipline; Significant experience in Study Management within a pharmaceutical or clinical background; Thorough knowledge of Patient Safety processes and local regulations
• Desirable: Advanced degree within field; Professional certification; Clinical study delivery operational experience; Project management experience

Key Relationship to reach solutions:
• Internal (to AZ or team): Study Management function; Development function; Other AstraZeneca employees
• External (to AZ): External service providers and regulatory bodies