Data Manager

Posted 12hrs ago

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Job Description

Data Manager managing clinical-trial databases, eCRFs, cleaning, queries, and coding. Supporting Eurofins bioskin’s dermatology-focused contract research services.

Responsibilities:

  • Create Case Report Forms (eCRF/pCRF)
  • Develop and maintain study databases
  • Coordinate data entry, data cleaning, and query management
  • Stay familiar with current scientific developments within the task area
  • Participate in and organize meetings, telephone conferences, training sessions, and seminars with in-house teams and clients
  • Develop and implement strategies for introducing clinical research databases according to ICH, GCP, and CDISC standards
  • Develop (e)CRF standard modules
  • Create and revise data management SOPs and associated workflows
  • Manage projects within data management activities
  • Prepare study-specific schedules and timelines in coordination with relevant departments
  • Create and adhere to audit-specific Data Management Plans and related documents
  • Define, program, and validate completeness and plausibility checks, edit checks, and data transfer
  • Conduct data review, data cleaning, and query management
  • Handle third-party and device data
  • Code diseases, adverse events, and drugs using study-specific systems such as WHO Drug Global or MedDRA
  • Organize and execute third-party and SAE reconciliation

Requirements:

  • University degree in natural sciences or other comparable degree
  • Working knowledge of ICH GCP guidelines
  • Experience in development of data structures according to CDISC standards would be a nice to have
  • Dependable, well-structured and organized, target-oriented personality
  • Team player
  • Well versed in English (written and spoken)

Benefits:

  • Full-time employment