Beschreibung
We are looking for someone who will:- Implement meta data structures in MDR which are used to automate and control the clinical dataflow process
- Maintain OC/RDC and/or RAVE global library questions, question groups, data collection modules and procedures
- Evaluate, release and maintain new standard elements
- Develop and implement mapping from different data structures to others and develop training material and train the global internal organization
- Guide Project Data Managers in data standards and mapping rules set-up
-? Perform a periodical review of the approved and used data standards as well as the continuous improvement of the harmonization across all therapeutic areas within BI worldwide (10%)
-? Suggest implementation strategy and migration topics (10%)
Required skills:
- Bachelor's degree in Information Technology, Mathematics, Medical Documentation or Informatics
- 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