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Title:Data Manager II
Salary:Open
Experience:3-5
Location:NJ - Summit

Description:
This position will experience leading studies from a DM perspective, preferably from Study Start-Up to Database Lock and work with CRO providers, to ensure that projects are completed on time and according to standards.

 

Responsibilities:
  • Protocol review
  • Provide input into CRF design and CRF completion instructions
  • Define data entry conventions
  • Define edit checks for data cleaning
  • Generate queries on clinical data to be sent to clinical sites for resolution
  • Update clinical database based on query resolutions
  • Perform coding of Adverse Events, Concomitant Medications, etc. in MedDRA and WHODRUG
  • Clean database by generating data queries, performing QC of data, reviewing data listings, etc.
  • Participate in project meetings when appropriate
  • Routinely interface with cross-functional team members
  • Train Data Management staff as appropriate Skills/Knowledge

Requirements:
  • 3-5 plus years Pharmaceutical or CRO industry experience
  • Experience using one or more databases systems, specifically Oracle Clinical
  • Experience and knowledge of the drug development process
  • Bachelor’s degree in life science, computer science, or related field, preferred
  • Excellent interpersonal, communication, and organizational skills

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