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Remote Principal Data Standards Specialist

Job is Expired
Location: Alabama, Alaska, Arizona, Arkansas, California, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, U.S. Virgin Islands, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming
Compensation: To Be Discussed
Staff Reviewed: Tue, Jan 26, 2021
Job Category: Information Technology
Weekly Hours: Full Time
Employer Type: Employer
Education Level: Bachelors

Job Summary

A biopharmaceutical company is filling a position for a Remote Principal Data Standards Specialist.

Must be able to:

  • Serve as a technical subject matter expert for CDISC and other industry/regulatory requirements
  • Develop, Review and Approve content within MDR ranging from data collection standards to reporting
  • Keep up-to-date about industry guidance releases including CDISC, Health Authority (e.g. FDA, PMDA etc.)

Skills and Requirements Include:

  • Minimal travel may be required
  • Undergraduate degree, preferably in a scientific or statistical discipline
  • Extensive working experience in the use of CDISC Standards for regulatory agency requirements
  • Strong working experience in clinical Metadata Repository (MDR)
  • Experience in submissions to a regulatory agency preferred
  • Experience in mentoring others in clinical trial process and CDISC Standards

COMPLETE JOB DESCRIPTION

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