Senior Manager, Clinical Operations

Added
15 days ago
Type
Full time
Salary
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Related skills

process improvement cross-functional teams clinical operations sop ich-gcp

📋 Description

  • Serve as the Clinical Process Owner for Clinical Operations processes, ensuring effective
  • Lead the development, review, harmonization, implementation, and maintenance of Clinical Operations
  • Identify and resolve process gaps, duplication, inconsistencies, conflicting requirements, and
  • Translate regulatory requirements, ICH-GCP principles, quality standards, audit and inspection
  • Lead and represent cross-functional process governance and decision-making, partnering with
  • Lead process implementation and change management, including impact assessment, stakeholder

🎯 Requirements

  • Bachelor’s degree in life sciences, healthcare, clinical research, business, or a related field
  • 5+ years of progressive clinical research or clinical operations experience in a CRO
  • Proven experience leading complex cross-functional or global process improvement initiatives from
  • Strong knowledge of clinical trial operations, clinical monitoring, site management, and
  • Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection readiness
  • Demonstrated ability to influence stakeholders, facilitate decisions, resolve conflicting

🎁 Benefits

  • Discretionary annual bonus
  • Health insurance
  • Retirement savings benefits
  • Life insurance and disability benefits
  • Parental leave
  • Paid time off for sick leave and vacation
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