Clinical Data Management Manager

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Location
Somerset, NJ
Salary
$115,000 - $125,000
Job Type
Direct Hire
Degree
Bachelor
Date
Apr 19, 2017
Job ID
2474279
Well-established, growing Medical Device Manufacturer seeks a Clinical Data Management Manager who will provide support to Clinical Operations, by developing an internal DataBase, Team and Infrastructure to support internal and external clinical research initiatives and audits.

Responsibilities of the Clinical Data Management Manager include:
  • Designs, develops and documents programs to process Clinical Data and perform statistical analysis
  • Develop programs to access data for reports according to specifications of the sponsors
  • Develop Quality Control processes to verify clinical data collected
  • Coordinate database design, development, implementation and maintenance and user support of clinical systems
  • Implement data management plans designed to meet project and protocol deadlines
  • Perform detailed analysis in order to identify trends and patterns of clinical study, marketing and sales areas
  • Performs root cause analysis on data anomalies and work data stewards for resolve issues
  • Generates Tables, Figures and Listings for statistical reports
  • Work with data management department and pharmaceutical companies when requests come in for additional data
Requirements for Clinical Data Management Manager:
  • Bachelor's degree in Statistics, Math or Computer Science and knowledge of SAS or VB or other computer language a must
  • 2-4 years of experience in Clinical Data Management for Clinical Trials
  • Must have experience with CDISC SDTM/CDASH
  • Must have experience in developing, validation, and implementation of EDC systems for Medical Device or Pharmaceutical Studies 
  • Experience with SAS (Base, Stats, Macro, etc.)
  • 2-4 years direct experience with SOP and infrastructure development activities