Local Study Director: Lead Countrywide Clinical Trials

AstraZeneca

United States

Sur place

USD 120 000 - 180 000

Plein temps

Il y a 11 jours

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Résumé du poste

AstraZeneca is seeking a Local Study Associate Director to oversee country-level study delivery, lead Clinical Research staff, and ensure compliance with ICH-GCP and local regulations. The LSAD will guide feasibility, site qualification, initiation, monitoring, and close-out while coordinating with Regulatory, Medical Affairs, and country leadership.

The role emphasizes budget management, study management systems, risk planning, and sponsor communication.

Qualifications

  • Bachelor’s degree in life sciences required.
  • Minimum of three years’ experience in development operations/CRA roles.
  • Strong knowledge of ICH-GCP guidelines.
  • Proven cross-functional leadership and project management.
  • Excellent communication and English language skills.
  • Willingness to travel nationally and internationally.

Responsabilités

  • Lead Local Study Team at country level to deliver studies on time.
  • Ensure compliance with ICH-GCP and local regulations.
  • Coordinate site selection, feasibility, and site visits.
  • Manage budgets and study-related documents.
  • Collaborate with Regulatory and Medical Affairs teams.

Connaissances

Leadership
Project management
English proficiency
ICH-GCP
Communication
Team-building
Organizational skills
Prioritization
Attention to detail
Negotiation
Travel
Learning new IT systems

Formation

Bachelor’s degree in Life Sciences

Description du poste

AstraZeneca is seeking a Local Study Associate Director to oversee country-level study delivery, lead Clinical Research staff, and ensure compliance with ICH-GCP and local regulations. The LSAD will guide feasibility, site qualification, initiation, monitoring, and close-out while coordinating with Regulatory, Medical Affairs, and country leadership.

The role emphasizes budget management, study management systems, risk planning, and sponsor communication.

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