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Clinical Data Manager

Wilmington, DE

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Description

Our Client has an immediate need for 2 Full Time Clinical Data Managers to join the team.

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 Client 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.
  • If applicable, overseeing that the Contract Research Organizations (CROs) utilized by Client Corporation (IC) perform data management activities in accordance with ICH/Good Clinical Practices (GCP).

Job Requirements

Minimum Requirements

 

  • A minimum of 3-5 years of data management experience is required.
  • 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.
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