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Clinical Study Associate Manager

$109.9k - $179.3k

Regeneron Pharmaceuticals, Inc.

Regeneron seeks a Clinical Study Associate Manager to support clinical trial delivery across internal and outsourced studies. The role involves overseeing study planning, vendor management, data quality, budget oversight, and regulatory compliance while collaborating with internal teams and external CROs.

Responsibilities

  • Lead or oversee clinical study planning and management across assigned regions in alignment with global protocols
  • Develop and review study-specific documentation including case report forms, monitoring plans, and patient-facing materials
  • Manage study systems setup and maintenance, including CTMS and TMF oversight
  • Monitor recruitment, retention, site activation, and data quality metrics throughout the trial
  • Support budget management, vendor contracting, and clinical supply forecasting and accountability

Requirements

  • Bachelor's degree and 4+ years of clinical trial operations experience
  • Proficiency in trial management systems, IVRS/IWRS, EDC, and MS Office applications
  • Knowledge of ICH/GCP guidelines and regulatory requirements
  • Experience developing clinical study documentation and vendor management
  • Data-driven problem-solving approach with strong attention to detail
  • Budget management awareness and familiarity with medical terminology
Vacancy posted 6 days ago
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