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Clinical Data Manager Wilmington United States,  

Incyte (company)


Posted on : 19 June 2017

Project Description

Description:
The Clinical Data Manager is responsible for performing activities pertaining to the conduct of Phase I ? III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met.


Job Responsibilities
  • Participate as the primary data management representative on company multidisciplinary project teams and ensure effective communication exchange 
  • Perform ongoing data review, including reconciliation of third party data streams and serious adverse event reconciliation with the safety database. 
  • Perform User Acceptance Testing (UAT) of clinical databases. 
  • Perform Quality Control (QC) of clinical databases. 
  • Generation and maintenance of data management related documentation 
  • If applicable, overseeing that the Contract Research Organizations (CROs) utilized by company  Corporation (IC) perform data management activities in accordance with ICH/Good Clinical Practices (GCP). 
  • Other duties, as assigned 


Minimum Requirements
  • A minimum of 3-5 years of data management experience is required.  
  • A Bachelor?s degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT) is preferred, but individuals with commensurate experience will be considered. 
  • Experience with Electronic Data Capture (EDC) system(s) is required. 
  • Experience with Oracle Inc.?s Inform? EDC system is preferred. 
  • Oncology and/or inflammatory therapeutic area experience is preferred. 
  • Project management experience (within Data Management) is preferred. 
  • Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is preferred. 

Locations

Wilmington DE

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