Job Description

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:

Ensures the processes for Study Delivery are executed through the development of study reports tools, facilitation of the study delivery system and maintenance of the system.


As an expert, ensures delivery of a centrally managed study management service across clinical studies from start up to reporting


Serve as main contact and works closely with the Document Management group until the Clinical Study Report is finalised


Initiates and maintains production of study documents, ensuring template and version compliance


Creates or imports clinical-regulatory documents into the Global Electronic Library according to the Global Document List


Interfaces with Data Management Centre or Data Management Enablement representatives to facilitate the delivery of study related documents


Manages and coordinates tracking of study materials and equipment


Monitors administrative tasks during the study process, audits and regulatory inspections, according to company policies


Acts as a technical owner within Patient Safety with a deep understanding of processes and internal regulations


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


Liaises with compliance team members to improve regulatory processes within the team


Identifies opportunities to improve the methodology and provide practical solutions for clinical development


Typical People Management Responsibility (direct / indirect reports):

Approximate number of people managed in total (all levels) - None


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; Experience of Study Management within a pharmaceutical or clinical background; Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management Desirable: Advanced degree within the field; Professional certification; Understanding of multiple aspects within Study Management


Key Relationship to reach solutions:

Internal (to AZ or team): Study management 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.


You can find alternative messaging to use in the 'Global Talent Attraction Story messaging' section of the Global Playbook on the Employer Brand Portal - try to use other examples in order to make it different for candidates!



So, what's next?

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours. Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/


Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/


Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en


If you have site, country or departmental social media then feel free to switch any of the above links.