Tasks

• Implementation of meta data structures in STAMM (MDR) which are used to automate and control the clinical dataflow process for the multiple studies within each project
• Maintenance of OC/RDC and/or RAVE global library questions, question groups, data collection modules and procedures
• Translation of OC/RDC database into BRAVE database and corresponding SDTM mapping
• Creation of study specific ALS files which will be uploaded into the RAVE system to create a study database
• Evaluation, release and maintenance of new standard elements
• Development and implementation of mappings from the different data structures (e.g. RAVE database, external lab data, external ECG data, etc. to SDTM data structures and development of corresponding training material.
• Creation of data standards and set-up of mapping rules
• Assess errors in the transformation program outputs to identify which area needs to be adapted (e.g. MDR, RAVE, SAS program) and perform corresponding correction
• Define and maintain EDC global library elements, including eCRFs, fields, data dictionaries, and procedure specifications.
• Define and/or approve trial database build specifications for implementation by database designers.
• Periodically review the approved and used data standards
• Review industry guidances and evaluate impact on BI data structures. Suggest implementation strategy and migration topics.
• Set-up data standards and mapping rules.
• Set up migration plans and mapping strategy for legacy projects.
• Develop oversight plans for external SDTM mapping

Skills

• Bachelor’s degree in Information Technology, Mathematics, Medical Documentation or Informatics or in a science related field.
• Experience in Clinical Data Management, Data Standards or drug development in areas intersecting with Clinical Data Management
• Detailed knowledge on CDISC models (main focus on CDASH and SDTM models) as well as familiarity with other data standards and models (e.g. ODM, ADaM, HL-7)
• Good knowledge of the flow of data (structure and format) from patient to report and application of this knowledge to data standards development
• Strong clinical knowledge and ability to liaise with trial- and project-teams
• Required conceptual thinking in complex situations
• Familiarity with clinical data standards tools and technologies
• Proficient knowledge in programming in SAS and/or SQL
• Excellent presentation and communication skills

Additional Information

Location: Biberach or Ingelheim

Project start: 11.02.2019

Duration: 10.02.2021

Availability: fulltime

On-site Support: Initial period 2-3 weeks

Afterwards: 1 week per month on-side, or completely homebased