Associate Director, Clinical Trial Patient Safety Job at AbbVie, North Chicago, IL

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  • AbbVie
  • North Chicago, IL

Job Description

Associate Director role overseeing clinical trial patient safety data review and surveillance operations at a pharmaceutical company. Manages cross-functional teams, ensures regulatory compliance, and implements process improvements within the CTPS organization.

Responsibilities

  • Oversee worldwide surveillance of clinical trial safety data with focus on compliance and quality
  • Manage 5-10 direct reports and establish workload metrics for assigned operational areas
  • Partner with medical monitors and therapeutic area physicians on safety review oversight
  • Develop and communicate training programs, staff development, and talent management initiatives
  • Ensure adherence to ICH, FDA, EMA regulations and implement departmental process improvements

Requirements

  • Bachelor's degree in life science, pharmacy, nursing, or related healthcare discipline
  • 10 years clinical research experience in pharmaceutical industry
  • Project management experience with cross-functional initiatives
  • Knowledge of drug development, clinical trial conduct, and regulatory requirements
  • Background in clinical operations, study management, or drug safety operations
  • Leadership and communication skills with ability to manage conflict and teams
  • Understanding of drug safety evaluation tools, standards, and approaches

Job Tags

Worldwide

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