Openings >> Clinical Data Manager Assistant (1 year full-time temporary)
Clinical Data Manager Assistant (1 year full-time temporary)
Summary
Title:Clinical Data Manager Assistant (1 year full-time temporary)
ID:2839/772
Location:Belfast, Northern Ireland
Department:Data Management and Biometrics
Job Status:Temporary
Description
Celerion is a leading clinical research company and we are looking for additional data management support in our Belfast, Northern Ireland research facility.

The Clinical Data Manager Assistant is responsible for the integrity of the clinical study data entered into a database and/or subject Case Report Forms. They also assist the Clinical Data Managers in study specific procedures.

This is a full-time temporary position for a period of 12 months

Essential Functions:
 
  • Perform data entry and verification for study specific Case Report Forms (CRFs)
  • Assist Clinical Data Manager in preparation and management of study materials including but not limited to QC Study File, Raw Data Storage Binder and Data Handling Manual.
  • Assist in the review source documents and raw data on an ongoing basis to ensure the following:
    • Medical history and ICF data is complete according to GCP and FDA guidelines and all subjects meet study eligibility according to the study protocol.
    • Clinical event source documents and raw data are complete according to GCP and FDA guidelines and protocol deviations (if applicable) are documented.
    • All deviations and documentation errors are sent to clinical staff for correction and updated as applicable.
  • Assist Clinical Data Manager with annotation of CRFs and laboratory reports (if applicable)
  • Perform Clinical Data Management Database QC steps as necessary
  • Assist Clinical Data Manager with corrections to the database
  • Assist Clinical Data Manager with logging in CRFs and laboratory reports received from Sponsor (if applicable)
  • Assist Clinical Data Manager in preparation of Final CRFs
  • Ensure Clinical Data Management complies with protocol and Celerion/Sponsor SOPs


Knowledge/Skills/Education requirements:

  • A-Level standard of education or equivalent
  • One year data entry experience preferred
  • PC scanning and document filing experience required
  • Competent computer data entry skills
  • Excellent oral and written communication skills
  • Excellent organizational skills
  • Knowledge of medical terminology preferred
Full training will be provided. 

Candidates invited to interview will be asked to complete a short aptitude test.

Closing date for applications is 20 February 2019.

Celerion is an equal opportunities employer.
This opening is closed and is no longer accepting applications
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