(sr.) Country Study Manager - Cell Therapy

AstraZeneca

5 years clinical operations experience
1 year local study team lead role
Ich-gcp and local regulation knowledge
The role requires serving as the SDTL Responsible to plan and lead the delivery of all clinical study components from specifications through closeout while ensuring time, cost, and quality targets are met

Job Summary

  • The role requires serving as the SDTL Responsible to plan and lead the delivery of all clinical study components from specifications through closeout while ensuring time, cost, and quality targets are met.
  • Candidates must lead a motivated Local Study Team consisting of monitors and administrators, ensuring compliance with ICH-GCP and local regulations while optimizing performance at the country level.
  • The position involves forecasting study timelines, managing budgets, coordinating with investigators for recruitment strategies, and facilitating regulatory submissions including Serious Adverse Event reconciliation.

Matching Summary

The role requires serving as the SDTL Responsible to plan and lead the delivery of all clinical study components from specifications through closeout while ensuring time, cost, and quality targets are met.

Skills & Requirements

Must-have

  • 5 years clinical operations experience
  • 1 year Local Study Team Lead role
  • ICH-GCP and local regulation knowledge
  • Study timeline and budget management
  • Patient recruitment strategy development
  • Audit and inspection preparation

Nice-to-have

  • Mentoring and team development skills
  • Experience with IMPACT and ACCORD systems
  • Strong stakeholder communication abilities
  • Knowledge of AstraZeneca procedural documents

Key Requirements

  • University degree in biological science or healthcare
  • Minimum 5 years experience in Clinical Operations
  • Working as LSTL for at least 1 year
  • Right to work in the advertised country

Work Rights

Must have right to work in the country where role is advertised

Tailored Resume

Cover Letter