Clinical Database Developer

Less than 5 years experience  • 

Salary depends on experience
Posted on 03/21/18
Less than 5 years experience
Salary depends on experience
Posted on 03/21/18

Responsibilities:

  • Act as the primary clinical databasedeveloper on FDA and Non-FDA regulated studies
  • Be responsible for clinical database programming SOP’s, templates and forms
  • Provide database system support, updates, and maintenance on all studies
  • Review protocols and eCRF/CRFs and provide feedback as needed
  • Develop, test, and validate clinical databases for eCRFs and CRF Studies 
  • Manage medical coding dictionaries (World Health Organization (WHO) Drug and MedDRA) in applicable clinical databases
  • Manage and maintain clinical databases (User Access, database updates, etc.)
  • Assist clinical data managers with clinical data reporting tools, database lock/unlock procedures and with clinical database archive procedures

SKILLS AND EXPERIENCE:

  • Demonstrated knowledge of FDA and ICH standards, including 21 CFR Part 11 and use of validated systems and associated processes
  • Excellent communication skills, both verbal and written

MINIMUM EDUCATION: Desires a minimum of a Bachelor’s degree in Computer Science related discipline and at least 3-7 years of clinical database development experience in a clinical or biotechnology industry.  A Master’s degree is preferred.

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