Global Study Manager

4 tygodni temu


Kraków, Lesser Poland TN Poland Pełny etat

Global Study Manager

The Global Study Manager is a member of the extended global study team supporting the delivery of clinical studies within Global Medicines Development (GMD) to time, cost and quality.

The role works cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with Global Study Associate Director (GSAD).

Key Responsibilities:
  1. Provides oversight to ensure study delivery in partnership with AZ enablement team, other AZ clinical experts and external service providers.
  2. Leads/contributes to the preparation of delegated study documents and external service provider related documents.
  3. Maintains interactions with internal functions including Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including CROs and other external service providers.
  4. Contributes to the planning and conduct of internal and external meetings.
  5. Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers.
  6. Identifies risks and issues, develops mitigation and/or action plans for identified risks and issues.
  7. Ensures that all study documents are complete and verified for quality in Trial Master File.
  8. Supports Global Study Associate Director with budget management and project management.
  9. Ensures that the study is inspection ready at all times.
  10. Manages CRO Project Manager for outsourced studies to ensure study delivery according to agreed timelines, budget and quality standards.
Requirements:
  1. Relevant experience from within the pharmaceutical industry or similar organization or academic experience.
  2. Excellent communication and relationship building skills, including external service provider management skills.
  3. Knowledge of international guidelines ICH/GCP.
  4. University degree, 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.


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