Clinical Data Manager

Location, NYC or NJ

ESSENTIAL DUTIES

 

Responsible for the planning, implementation, and coordination of all data management activities supporting clinical trials in multiple therapeutic areas, from study start-up to database finalization.   Give guidance to the SAS Programmers/Analyst, Data Management Associates.

GENERAL DESCRIPTION

 

  • Reviews the CRF and provides annotations according to company standards
  • Develops and maintains the data management plan, data validation plan, data transfer specifications, and database set-up instructions
  • Performs acceptance testing on database applications and data transfers
  • Maintains study databases and releases updated SAS datasets for statistical analysis on a regular and timely basis
  • Reviews data listings for the accuracy, completeness and consistency of data
  • Manages the clinical trials data cleaning activities
  • Maintains documentation of all data management activities
  • Interacts with study group members in Clinical, Application Development, Pharmacovigilance, and Biostatistics to ensure that data are complete, accurate, and in compliance with regulatory requirements
  • Prepares documents for clean file meetings and database lock
  • Translates requests for simple to complex statistical analysis, data preparation, data manipulation, and reporting tools into SAS programs and macros
  • Participates in the validation/QC of SAS programs, analysis datasets and data entry
  • User training of EDC

 

MINIMUM REQUIREMENTS

 

  • BS in Statistics, Computer Science, Business/Economics/Marketing or Science related field
  • 3 years of experience in clinical data management
  • SAS programming experience is not required but is a plus
  • Knowledge of regulatory guidelines pertaining to data quality and data management
  • Familiarity with electronic data capture tools
  • Strong analytical skills, excellent attention to detail and documentation skills
  • Clinical trials experience
  • Excellent Communication skills
  • Good organizational skills