Clinical Data Manager

Clinical Data Manager

Incyte

Geneva, Switzerland

Summary

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.

Duties and Responsibilities

  • Participate as the primary data management representative on Incyte 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 Incyte Corporation (IC) perform data management activities in accordance with ICH/Good Clinical Practices (GCP).

Other duties, as assigned

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.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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