Director, Clinical Data Management Job at PTC Therapeutics, Warren, NJ

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  • PTC Therapeutics
  • Warren, NJ

Job Description

PTC Therapeutics seeks a Director of Clinical Data Management to lead strategic and operational oversight of clinical database quality, integrity, and regulatory readiness. The role involves cross-functional leadership, vendor management, and direct responsibility for data management processes across clinical trials.

Responsibilities

  • Provide strategic oversight of clinical database quality, integrity, and inspection readiness
  • Lead CRO oversight and manage data management plans from initiation through completion
  • Partner with clinical operations, biostatisticians, and programmers to design data collection instruments
  • Oversee adverse event coding, medical history review, and database cleaning activities
  • Develop and update standard operating procedures and best practices documentation

Requirements

  • Bachelor's degree in science or healthcare-related field
  • Minimum 10 years progressive experience in pharma, biotech, CRO, or regulatory agency
  • Proven track record leading data management teams
  • Experience with IWRS, imaging, ePRO/eCOA, and database technologies
  • Strong attention to detail and ability to manage multiple priorities
  • Knowledge of regulatory compliance and clinical trial data standards

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