Local Study Associate Director
About AstraZeneca
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
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
Why AstraZeneca?
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.