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(Archived) 2873 Associate Director, Global Clinical Trial Studies

Last Updated: 9/23/22

Job Description

Job description:

Opportunity to work with a world renowned oncology research and development team, leading GLOBAL studies from early through late phase. On site in GTA office preferred / some remote OK.

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.

Qualifications:

REQUIREMENTS:

  • BS, [Register to View] MS, [Register to View] 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.
Why is This a Great Opportunity:

Great company - leader in the field

Lots of room to move up

Interesting projects

Interaction with people all over the world

Company Details

Grand Rapids, Michigan, United States
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