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Associate Director, Clinical Affairs

Becton Dickinson & Co

Waters seeks an Associate Director of Clinical Affairs to lead global clinical study operations for the Biosciences business. The role oversees clinical project execution, manages a team of clinical professionals, and ensures regulatory compliance and evidence generation for in vitro diagnostics and related technologies.

Responsibilities

  • Plan, execute, monitor, and close global clinical studies ensuring timeline, budget, and quality delivery
  • Provide strategic oversight of study management, enrollment, site management, and risk mitigation
  • Manage study budgets, contracts, vendor engagements, and resource allocation
  • Lead and mentor global team of Clinical Project Managers and Clinical Research Associates
  • Partner with cross-functional teams on clinical research planning and regulatory support

Requirements

  • Bachelor's degree in scientific discipline or related life sciences field
  • Minimum 10 years clinical research, clinical operations, or clinical affairs experience
  • Proven track record delivering global or multi-center clinical studies
  • Experience managing Clinical Project Managers and Clinical Research Associates
  • Strong knowledge of FDA regulations, ICH-GCP, ISO 14155, and clinical research regulations
  • Experience with in vitro diagnostics, molecular diagnostics, genomics, or proteomics
  • Demonstrated vendor management and CRO oversight capabilities
Vacancy posted 20 days ago
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