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Global Study Manager Role

2 tygodni temu

Warszawa, Mazovia, Polska TN Poland Pełny etat

Job Summary:

The Global Study Manager role is a critical position within our organization, supporting the delivery of clinical studies worldwide. As a member of an extended global study team, you will work closely with internal and external partners to ensure timely, cost-effective, and high-quality study execution.

This leadership role involves cross-functional collaboration, oversight, and management of delegated aspects of clinical study execution. You will provide strategic guidance and support to enable successful study delivery in accordance with established protocols.

Main Responsibilities:

  1. Oversee study delivery in partnership with AZ enablement teams, other clinical experts, and external service providers.
  2. Contribute to the preparation of delegated study documents and external service provider-related materials.
  3. Maintain and facilitate interactions with internal and external functions to ensure efficient study delivery.
  4. Support planning and conduct of internal and external meetings (Investigators'/Monitors' meeting).
  5. Liaise with Clinical Supply Chain or external service providers to ensure Investigational product and study material supply.
  6. Proactively identify risks and issues, develop mitigation plans, and implement corrective actions.
  7. Ensure all study documents are complete and verified for quality in Trial Master File.
  8. Support budget management, including external service provider invoice reconciliation.
  9. Adhere to global clinical processes, procedural documents, and international guidelines to ensure study inspection readiness.
  10. Take on assignments related to process improvements and leading improvement projects.

Requirements:

  1. Relevant experience in pharmaceutical industry or similar organization, preferably 3+ years - knowledge of clinical development/drug development process in various phases.
  2. Excellent communication and relationship building skills, including external service provider management.
  3. Knowledge of international guidelines ICH/GCP.
  4. University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
  5. Demonstrated ability to collaborate and work independently.
  6. Leadership skills.
  7. Computer proficiency and advanced computer skills.
  8. Excellent verbal and written communication in English.