Sr. Clinical Data Management Specialist

Location: San Francisco, CA

Responsibilities:

  • Under general direction, responsible for the planning, implementation and overall direction of executing/achieving clinical trial data management activities
  • Manage Contract Research Organizations (CROs) and service providers’ activities in overseeing the data management process life cycle
  • Work with clinical, biostatistics and regulatory teams to design, document, test and implement data collection instruments and study documents
  • Manages the interaction with contract data management vendors to ensure that data management tasks remain on target according to project timelines
  • Assists in development of data review plans and proactively organizes on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies by working with a contract data management vendor
  • Responsible for correcting errors and discrepancies through the site query process, documenting permanent data issues, routinely communicating issues with team members and delivering a quality locked database for analysis
  • Contribute to the development and implementation of departmental policies, standards and process improvement initiatives

Requirements:

  • 3-5 years of experience in Clinical Data Management
  • BA Degree in clinical, biological or mathematical sciences or related field or nursing qualification
  • Advanced knowledge of Data Management processes and systems
  • Outstanding written and oral communication skills
  • Solid understanding of clinical drug development process is preferred
  • People management experience is preferred
  • Excellent organizational skills and demonstrated ability to manage projects
  • Effective problem solving skills