24 days ago on ctcon.ch

Senior Data Manager

CTC Clinical Trial Consulting AG

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  • Employment type
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 Please refer to JobSuchmaschine in your application

Senior Data Manager

Reference Number: 895009-W
Type of placement: Contract, 24+ Months – Strong possibility to turn permanent
Location: Switzerland, North West


  • Responsible to manage contract research organizations (CROs) performing data management and statistical tasks for clinical studies.
  • To ensure that the deliverables are provided on time, to a high level of quality and adhering to company requirements and to support clinical review of study data in SAS.
Main Responsibilities:

  • Actively manage studies performed by CROs for Data Management and Statistics (contracts, payments, timelines, quality, cost and deliverables)
  • Review and approve Data Management and Statistics study deliverables provided by the CRO (eCRF/database set-up, data management plan, statistical analysis plan, datasets (CDISC), tables, figures and listings) in order to ensure compliance with the study protocol and company standards
  • Lead the study team review of Data Management and Statistics deliverables
  • Provide regular feedback to company study team on study progress and activities at the Data Management and Statistics CRO
  • Regular review of study data with the clinical team/ safety team.
  • Support clinical review of data in SAS (JMP /JMP Clinical)
  • Lead database lock plans and activities
  • Coordinate development of the PK analysis between the Clinical Pharmacologist and the Statistics CRO
  • Perform ongoing filing of study documentation and data in document management system
  • Follow departmental policies, procedures, and SOPs
Qualifications and Experience:

  • Extensive knowledge of all aspects of data management for all phases of studies, in particular Phase III global registration trials
  • Good knowledge of the development of randomization lists, statistical analysis plan, allocation to analysis populations and the content of clinical study output
  • Experience in regulatory submissions which include datasets is preferred
  • Fluent written and spoken English.
  • Knowledge of German is also an advantage
  • Good knowledge of SAS programming. Experience in SAS JMP/JMP Clinical an advantage
  • Good knowledge of SDTM and CDASH standards.
  • Strong Leadership skills
  • Integrity and flexibility
  • Able to work without supervision and to take responsibility for tasks
  • Attention to detail
  • Good written and verbal communication skills
  • Risk awareness
  • Relevant working/residency permit or Swiss/EU-Citizenship required