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Title:Director, Clinical Data Manager
Location:CA - South San Francisco

The Head of Clinical Data Management (CDM) is accountable for the overall management, leadership and strategic direction for the Clinical Data Management department.

  • Design, develop and implement data collection processes, operational databases, and data quality processes to enable delivery of accurate, reliable and fully documented data for all development and commercial projects.
  • Provide vision and strategic direction/planning for CDM, partnering with Development functional leaders to operationalize clinical trials, managing and coaching staff, resource planning and management of departmental budget.
  • Overseeing hiring, training and development of staff and overseeing evaluation, development, implementation and maintenance of tools, processes, best practices and standards.

  • Excellent management and leadership skills, ability to build effective, collaborative team environment
  • Strong interpersonal and communication skills, ability to communicate effectively at all levels of the organization
  • Demonstrated excellent multi-faceted problem-solving and decision-making skills
  • Excellent organizational skills
  • Demonstrated ability to take ownership and assume accountability for process improvement initiatives
  • Thorough understanding of GCP, other FDA guidelines relating to CDM and industry conventions (e.g., SCDM's GCDMPs)
  • Comprehensive understanding of the conceptual basis for clinical data management conventions, standards and processes
  • Clinical data management system experience
  • Comprehensive understanding of a clinical research department's role in drug development
  • BA/BS and/or MA/MS  in biological sciences, computer science or equivalent
  • At least 10 years experience in the pharmaceutical/biotech industry with an emphasis in clinical data management
  • A minimum of 6 years of personnel management experience

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