Data Management Manager

Reference Number: 896300-W
Type of placement: Contract, 12 months

Introduction:

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 the 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;
  • Lead study team review of Data Management and Statistics deliverables;
  • Provide regular feedback to study team on study progress and activities at the Data Management and Statistics CRO;
  • Regular review of study data with 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:

  • Master Degree in Life Sciences, computational sciences
  • At least 5 years’ experience as a data manager for clinical trials and extensive knowledge of all aspects of data management for all phases of studies
  • Good knowledge of the development of randomization lists, statistical analysis plan, allocation to analysis populations and the content of clinical study output;
  • Experience management of CROs for data management activities
  • Significant experience with EDC systems such as Rave or Inform;
  • Programming experience with SAS or SAS certification;
  • Knowledge in SAS JMP/JMP Clinical and CDISC standards is an advantage;
  • Fluent written and spoken English; knowledge of German is an advantage;
  • Team worker with high level of integrity, flexibility & organizational skills, and a hands-on approach;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

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