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Associate Director, Global Clinical Trial Studies
Toronto, ON

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This is a great opportunity to work with a world-renowned oncology research and development team to lead GLOBAL studies from early through late phase. On site in GTA office preferred / some remote OK. 
 
  • Great company - leader in the field
  • Lots of room to move up
  • Interesting projects
  • Interaction with people all over the world
  • Bonus, great benefits, RRSP contribution, etc.
 
ROLE AND RESPONSIBILITIES:
 
  • Leading a cross-functional clinical study team from onset of study specifications to study archiving.
  • Help team deliver studies or projects, meeting time, budget, quality, following ICH/GCP and company SOPs.
  • Serve as contact for CRO project manager to ensure work outsourced to CRO follows company guidelines.
  • Keep global study plans up to date.
  • Study budgets.
  • Risk and contingency planning.
  • Development of critical study level documents, such as Clinical Study Protocol.
  • Select and lead vendors.
  • Training for local and site teams and participating in monitoring and investigators meetings.
  • Keep studies ready for inspection and meeting ICH-GCP and company SOPs.
  • Main point of contact re audit re Trial Master File TMF.
  • Adverse events collection.
 
REQUIREMENTS:
 
  • BS, B.Sc., MS, M.Sc., PhD biological sciences. PMP nice to have.
  • Background in oncology trials.
  • Min 7 years of relevant clinical experience in the pharmaceutical or CRO industry leading global trials.
  • Great grasp of study management and clinical operations, phases of development, and therapy areas.
  • Min 5 years global clinical project management experience.
  • Cross-functional team leadership, budgets.
  • Strong communication skills, able to build positive relationships, and vendor leadership skills.

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