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Title:Clinical Data Coordinator II/III
Salary:Open
Experience:2-6
Location:MD - Gaithersburg

Description:

Participate in the data collection and management of routine to moderately complex clinical trials to ensure processing is completed within a defined timeframe. Assist CDM management in CDM projects.

  •     e.g. assist with preparation and revision of department SOPs and WPDs etc.

Responsibilities:
  • Provide data management support for multiple and/or complex clinical trials under the supervision of experienced clinical data management personnel.
  • Logically translate the data requirements from protocol to CRF to database structure utilizing understanding of database architecture and its impact on data management processes and eCRF/CRF design
  • Participate in or lead the design development testing and implementation of tools and activities that promote the timely completion of studies e.g. database eCRF/CRF edit check programming etc.
  • During a study identify data trends and develop strategies for managing them as needed e.g. implementation of assumptions training or revision to CDM deliverables
  • Actively review discrepancies within clinical database to clean the data
  • Create test data
  • Participate in User Acceptance Testing (UAT) for EDC studies
  • Create and maintain study documentation
  • Provide proper correspondence and study documentation to ensure data quality
  • Assist with User Management Portal Administration and study team support for EDC studies
  • Receive log enter and store copies of CRFs and DCFs as needed
  • Review discrepancies within clinical database to clean study data
  • Create queries to be sent to sites and close the returned queries
  • Actively manage query process
  • Perform database updates
  • Review data listings for accuracy and consistency of data
  • Identify questionable data and potential medical issues; refer to appropriate resource
  • Review and address QC findings from CRF and DCF vs. datbase review
  • Prepare present and train the sites CRAs and Investigators on eCRFs/CRFs
  • Maintain working knowledge of corporate and departmental SOPs and WPDs and awareness of organizational SOPs
  • Provide back up support to other staff members as required
  • Act as Lead Data Manager for studies if appointed
  • Resolve complex team/data management issues utilizing key resources to facilitate problem resolution
  • Communicate milestones and practices with respect to team members and management
  • Manage external vendors
  • Utilize presentation skills to make professional clear presentations to groups internally and occasionally externally
  • Liaise between CDM and other Medical Organization departments as needed for study-related CDM activities
  • Provide ongoing feedback regarding project issues to lead data manager or department management
  • Communicate clearly and effectively at all levels
  • Produce organized concise and grammatically correct written communication
  • Work as a team member developing respect and confidence of technical peers

Requirements:
  • 2-6 years clinical data management experience (in a biotechnology or pharmaceutical company or at a Contract Research Organization)
  • Experience managing people/project required for a CDC III role.
  • Proficient in Microsoft Office
  • Prior experience with Oracle Clinical Phase Forward InForm medical coding dictionaries
  • Working knowledge of software utilized for external data review i.e. I-Review Cognos Reporting etc.
  • Working knowledge of medical terminology
  • Must be able to work with minimal supervision
  • Requires some instruction and supervision for new tasks
  • BS/BA with a minimum of 2-3years of experience
  • HS diploma/some college with a minimum of 4-5 years of experience

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