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AstraZeneca is seeking an Associate Country Study Manager to oversee and ensure the timely delivery of clinical studies, focusing on quality and compliance. The role involves leading cross-functional teams, managing resources and budgets, and contributing to recruitment strategies and regulatory submissions.
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Job Summary
The role requires serving as the SDTL Responsible for planning and leading the delivery of all clinical study components from specifications through closeout.
Candidates must lead a motivated Local Study Team, ensuring compliance with AZ Procedural Documents, ICH-GCP, and local regulations while managing study timelines and budgets.
The position involves active participation in steering committees, submission assembly teams, and regulatory defense teams to ensure high-quality study results.
Matching Summary
Match Score: 75
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AstraZeneca is seeking an Associate Country Study Manager to oversee and ensure the timely delivery of clinical studies, focusing on quality and compliance. The role involves leading cross-functional teams, managing resources and budgets, and contributing to recruitment strategies and regulatory submissions.
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Skills & Requirements
Must-have
Lead Local Study Team (LSTL)
5 years R&D Clinical Operations experience
ICH-GCP and local regulatory compliance
Study timeline and budget management
Investigator recruitment strategy
Audit and inspection preparation
Nice-to-have
Mentoring and staff development skills
Cross-functional collaboration abilities
Strong English communication skills
Adaptability to IT systems like IMPACT
Experience with strategic planning
Key Requirements
University degree in biological science or healthcare
Minimum 5 years experience in R&D Clinical Operations
At least 1 year working as LSTL
Right to work in the country of advertisement
Work Rights
Must have right to work in the country where the role is advertised