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Clinical Study Manager

2 months ago

Sydney, New South Wales, Australia Pfizer Full time
About the Role

Pfizer is seeking a highly skilled and experienced professional to join our medical team as a Site Care Partner. This role is responsible for managing clinical studies, ensuring they are completed within time, budget, and scope.

Key Responsibilities
  • Develop and manage plans to achieve objectives, interpreting internal and external business challenges and recommending best practices for improvements.
  • Approve Study Startup, Study Monitoring, and protocol recruitment plans.
  • Resolve escalated issues identified by the site activation subteam in partnership with the Study Manager.
  • Work proactively with Clinical Research Organizations (CRO) and data management functions to ensure alignment on data flow and timely delivery.
  • Manage Operational Study Management for one or more studies of limited complexity or a unique part of a larger study.
  • Forecast and manage the Clinical Trial Budget for the program.
  • Provide country and regional level input to country outreach surveys.
  • Create awareness by working as a cross-functional Team Leader to deliver site intelligence initiatives with a variety of stakeholders, both internal and external.
  • Approve and oversee drug supply management, manage flow of drug supply to the sites.
  • Participate in global initiatives to improve operational efficiencies.
  • Evaluate study progress reports and results for overall compliance and recommends corrective action or study termination for non-performance.
  • Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
Requirements
  • Bachelor's Degree
  • 7+ years' experience in the pharmaceutical industry
  • Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
  • Demonstrated project management/leadership experience
  • Experience with CRO oversight
  • Ability to evaluate, interpret, and present complex issues and data to support risk
  • Excellent communication skills, both written and verbal; must be fluent in English
  • Effective decision maker, analytical, and solution-oriented
  • Proficiency in Microsoft Office Suite