Senior Data Manager (m/f)

REFERENZNUMMER:

303858/11

IHRE AUFGABEN:

-Actively manage studies carried out by CROs for data management and statistics (contracts, payments, timelines, quality, cost and deliverables)
-Ensure that the deliverables are provided on time, on a high level of quality and adhering to the vendor's requirements and to support the clinical review of study data in SAS
-Review and approve Data Management and Statistics study deliverables provided by the CRO (data management plan, statistical analysis plan, datasets (CDISC)) in order to ensure compliance with the study protocol and company standards
-Lead company study team review of Data Management and Statistics deliverables
-Regular review of study data with clinical team/safety team
-Support clinical review of data in SAS (JMP /JMP Clinical)
-Coordinate development of the pharmacokinetic analysis between the Clinical Pharmacologist and the Statistics CRO
-Perform ongoing filing of study documentation and data in company's document management system

IHRE QUALIFIKATIONEN:

-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 randomisation lists, statistical analysis plan, allocation to analysis populations and the content of clinical study output
-Experience in working in a sponsor company and not only in CROs
-Experience in regulatory submissions which include datasets in of advantage
-Fluency in written and spoken English, knowledge of German is also of advantage
-Good knowledge of SAS programming, experience in SAS JMP/JMP Clinical is of advantage
-Good knowledge of SDTM and CDASH standards
-Strong leadership skills

WEITERE QUALIFIKATIONEN:

Clinical data manager