Available Positions

Clinical Data Manager - CDISC/CDASH Standards Expert at Pharmaceutical Company in Philadelphia, Pennsylvania, United States —

  • Pharmaceutical
  • Pharmaceutical Company
  • Philadelphia, Pennsylvania, United States
  • 10/11/19

Job ID: 62578

Job Description

Principal duties include:

  • Review protocols and coordinate study set-up activities for trials
  • Define data collection methods based on protocol aims
  • Collaborate with study team members to determine metadata specifications
  • Program forms within the EDC system as per specifications
  • Identify and program edit checks and online Web logic specifications
  • Perform user acceptance testing
  • Prepare CRF and/or Web entry completion guidelines
  • Create standard, study specific, and ad hoc reports using B04, JReview, SAS, etc…
  • Program database updates as needed per protocol amendments
  • Perform quality control review checks and assist with final database lock activities
  • Perform data transfers from the EDC system to sponsors, including validation and QC of transfers

Qualifications

Qualified candidates will possess the following:

  • Professional nursing degree/other healthcare certification/Bachelors degree in Life Science or BS degree and 2+ years of programming EDC systems for clinical trials required.
  • Experience in a multi-modality clinical trials group or research team a plus.
  • Certified Medidata Rave® Study Builder, C#, and SAS programming a plus
  • CDISC experience a plus

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