Global Clinical Study Manager

AstraZeneca; Warszawa; On-site; PLN 180,000 - 280,000; Full time

Job summary

AstraZeneca is seeking a Global Study Manager to join the extended global study team. You will support delivery of clinical studies from CSP development to CSR and archiving, working with internal and external partners to meet time, cost, and quality goals.

You will lead preparation of study documents, maintain CRO relationships, and ensure quality in the Trial Master File, while supporting budget management and adherence to AZ SOPs and regulatory guidelines.

Qualifications

• Essential: university degree in medical/biological sciences or related field.
• At least 3 years of relevant experience in pharma or related organization.
• Knowledge of clinical development and ICH/GCP guidelines.
• Excellent written and verbal English communication skills.
• Strong project management and crossFunctional collaboration abilities.

Responsibilities

• Oversee study delivery in partnership with AZ team and external providers.
• Contribute to preparation of delegated study documents and external service provider docs.
• Liaise with internal and CRO partners to ensure on-time, on-budget, high-quality delivery.
• Plan and conduct internal/external meetings (Investigators’/Monitors’ meetings).
• Ensure supply of Investigational product and materials with Clinical Supply Chain or providers.
• Identify risks early and develop mitigation plans.
• Ensure trial master file documents are complete and audit-ready.
• Support budgeting with GSD/GSAD and external providers.

Skills

Biomedical degree

3+ years pharma

ICH/GCP knowledge

English fluency

Project management

Cross-functional collaboration

Leadership

Communication

Computer skills

Education

Bachelor's degree in medical/biological sciences

Job description

AstraZeneca is seeking a Global Study Manager to join the extended global study team. You will support delivery of clinical studies from CSP development to CSR and archiving, working with internal and external partners to meet time, cost, and quality goals.

You will lead preparation of study documents, maintain CRO relationships, and ensure quality in the Trial Master File, while supporting budget management and adherence to AZ SOPs and regulatory guidelines.