Jobbeschreibung

Positionsnummer / Reference Number

PA1201228052020

Position / Job Title

Senior Data Management Manager

Aufgaben / Tasks

•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 company’s requirements and to support clinical review of study data in SAS.
•Lead the study team review of Data Management and Statistics deliverables
•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 the company’s standards
•Provide regular feedback to the 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

Qualifikationen / Qualifications

•Master’s degree in Life Sciences, computational sciences
•At least 5 years’ experience as a data manager for clinical trials
•Significant experience with EDC systems such as RAVE or Inform
•Project management and programming experience
•Experience in the field of oncology
•High organizational, analytical, and administrative abilities
•Customer focus
•CRO management
•Fluent in English oral / written

Weitere Informationen / Further Information

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