Beschreibung
For a pharmaceutical client we are currently searching for a Senior Clinical Programmer Metadata Management (m/w/d).Location: Marburg
On-Site: 80 %
Home-Office: 20 %
Duration: 2 years
Start: 1st of August
Language: English
Your Tasks:
- Defines the data collection for clinical studies by creating data definitions in the metadata repository and by using programmatic Tools
- Creates eCRFs in the Medidata Rave EDC systems by implementing defined data collection standards into the study and amend it with study specific customizations and additions
- Implement edit checks according to the company's standard and ensure their usability in studies
- Supports the definition of metadata for non-eCRF data sources in the metadata repository system to allow automated processing of incoming and outgoing data for all data sources used in clinical studies.
- Supports the mapping of data collected in eCRFs or eCOA tools into standardized formats following the CDISC standard to enable standardization and data pooling
- Collaborates in the development of strategies for the integration of non eCRF data in the eCRF database (eg, IRT integration) provides technical support to internal team members as well as to external vendors as requested by study teams
- Collaborates in the set-up and maintenance of a suite of reports (eg, metadata QC reports, clinical data listings, dashboard reports on operational data)
- Collaborates with peers, data management, statistics and external service providers to ensure the quality and accuracy of clinical data collected in the studies. Manages the review of related deliverables with internal teams and external vendors
- Supports CD staff in any data standards related questions
Your Profile:
- Degree (BSc/MSc/Diploma) in Computer Science, Mathematics/Statistics, or related area with relevant experience
- Other degrees and certifications considered if commensurate with related data management experience
- At least 3 years of experience in either clinical data management and / or statistical programming, within the CRO / pharmaceutical Environment
- Understanding of data management and / or statistical programming processes and standards including standards metadata management
- Strong knowledge in CDISC standards (CDASH, SDTM, ADaM)
- Good SAS programming skills
- Strong Medidata Rave knowledge in study build, edit check programming
If this position is of interest to you, I am looking forward to your CV as word document via e-mail via I will get back to you shortly.