Study Start Up Manager
About The Position
The Study Start-Up Manager is pivotal at the country level, orchestrating start-up activities to align with AstraZeneca's procedures, local and international guidelines such as ICH-GCP, and relevant regulations. This role involves detailed preparation, review, tracking, and management of site regulatory documentation. The manager will also maintain and report on site performance metrics, collaborating closely with Clinical Research Associates (CRAs) and the Local Study Team to ensure efficient and timely study start-up activities. At AstraZeneca, we embrace opportunities for change to drive meaningful advancements. Our mission is clear: to deliver life-changing medicines and redefine possibilities in biopharma. By combining diverse perspectives, pioneering science, and ambitious ideas, we are transforming patient outcomes worldwide.
Requirements
- Minimum of 3 years of current or recent full-time work as a Clinical Study Start-Up Lead.
- At least 1 year of hands-on experience with Veeva Vault.
- Demonstrated expertise in a lead start-up position with robust skills in communication, organization, and project management.
Responsibilities
- Manage and conduct start-up activities at the country level, ensuring compliance with AstraZeneca procedures and relevant regulations.
- Prepare, review, and track site regulatory documentation; maintain and report on site performance metrics.
- Collaborate with CRAs and Local Study Teams to ensure timely and efficient study start-up activities.
Benefits
- Competitive base salary, annual bonus, and long-term incentives
- Generous paid time off program
- Comprehensive benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
