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Study Data Manager

Keyrus Biopharma

Belgium

Job Description

  • To reinforce our functional services platforms, we are looking for a Study Data Manager being responsible for the coordination of all Data Management activities to be delivered for the clinical study(ies)
  • Direct and main responsible of the data management deliverables (timing and quality) for the study.
  • Responsible for eCRF development and implementation: specifications, development, approval, QC, Workflow rules implementation, edit check validation, UATs,....
  • Accountable for the Database development being SDTM Compliant
  • Responsible for development and approval of subject diaries and other paper documents
  • Responsible for the oversight of data cleaning activities
  • Responsible for the QC of data cleaning
  • Responsible for the Freezing and Archiving
  • Matrix collaboration with the Oversight Data Managers,Data Standard Managers, Analysts and Programmers in charge of the technical parts of the study, Clinical Data Reviewers for the data cleaning activities and Study Delivery Leads.

Profile

  • Education: Master or equivalent experience. Preferably Engineering, Biological Sciences or Computer Sciences
  • Knowledge/skills:
  • Good communication skills
  • Assertiveness and ability to build impactful relationship
  • Excellent organizational and planning skills, analytical mind
  • Data Management and Clinical Trials Business understanding
  • Fluent in English
  • Experience: 3 to 5 years in Clinical Data Management. Ideally in a Coordination/Project management role.

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