(associate) Country Study Manager - Cvrm

AstraZeneca

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Lead local study team (lstl)
5 years r&d clinical operations experience
Ich-gcp and local regulatory compliance
** 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. **

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

** 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. **

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

Tailored Resume

Cover Letter