Job Details

  • Title: Sr. Data Manager
  • Code: RCI-8754
  • Location: Berkeley Heights New Jersey (NJ) 07922
  • Posted Date: 11/07/2019
  • Duration: 12 Months

  Job Description

  1. Manage outside CROs and consultants:

 

  • Perform QC of CRO activities to include Query management, Data review, DM documentation such as edit checks, lock process
  • Monitor progress of data management activities by CROs
  • Participate in regular team meetings and provide input when appropriate

 

  1. Other Activities:

 

  • Interact with CRAs, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries
  • Regularly reconcile the Safety database to the EDC database

 

Skills/Knowledge Required:

 

  • Must have relevant and extended experience.
  • Must be able to work with minimal supervision.
  • Must be able to communicate well.
  • Must have experience in managing data management deliverables end to end.
  • Project and task driven
  • BS/BA degree or equivalent in a relevant scientific discipline with a minimum of FIVE years’ experience as a data manager, or equivalent, in a pharmaceutical/CRO setting
  • Advanced knowledge of Excel, will be given preference over other candidates
  • Knowledge of Medical Affairs helpful
  • Experience in Hematology and/or Oncology
  • Proficient knowledge of EDC databases, preferably Medidata RAVE.
  • Excellent communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers
  • Proficiency in regulatory guidelines, agencies, GCP
  • Knowledge of clinical trial process and data management process