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Jr. Data Manager

Job description

As a Junior Clinical Data Manager, you will:

  • Provide Clinical data management support to the Data Manager and A-CRO team and for the Research team for the Studies and projects selected by A-CRO division and the Clinical Trial Network
  • Assist in defining and/or create data listings, summary tables, data reports, status reports (in excel and PDF forms) to support data review (including medical data review, data review by sponsor, coding data review, systematic data review by data manager, reconciliation data review etc.,)
  • Process queries generated using automatic checks and performs comprehensive manual data review on clinical data.
  • Identify data related issues during data review and work towards resolution
  • Interface between site and data management to ensure prompt query resolution
  • Participate in the review of Clinical research documents (e.g. Protocols, Case Report Forms, Reports and Statistical analysis).
  • Support in development of Case Report Form (CRF), electronic and/or paper,
  • Support in development database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, and query logic and data validations, Data management documents.
  • Support in reconciliation of electronic data transfers from vendor to Sponsor.
  • Develop test scripts and execution logs for User Acceptance Testing (UAT).
  • Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
  • Support to Data manager in EDC access management
  • Provide data management support during Audits.
  • Participate in conference calls and/or meetings with vendors.
Skills and personality
  • Bachelor’s degree in a science/IT related field
  • At least 1-2 years of relevant experience within Data management in Clinical Trial sector, either within industry or within a non-profit organization or CRO.
  • Experience preferred in clinical data review and the use of review and listing tools
  • Basic working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • Good knowledge of Office tools mainly Microsoft Excel.
  • Working knowledge of Clinical database applications for EDC.
  • Applicable knowledge working with clinical databases such as Oracle Clinical, Oracle etc., SAS, Coding of medical terms etc.,
  • Enthusiastic person, pro-active, reliable, and flexible. Team player with the ability to work independently and autonomously.
  • Excellent verbal and written communication skills in English. Any other language is a plus. Good organizational, interpersonal, and team skills.
  • Good Project coordination skills.
Contract

Project staffing

Experience

minimum 2 years

Education

Higher Education

Languages

English

Sector

Healthcare

Region

Brussels

Job type

1 year contract - full time

 
 

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