Data Management Manager
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.
- 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.