David Schirmer

Global Data Operations • Provide leadership to ensure the project or program is completed within budget, schedule and according to contract specifications • Thorough knowledge of all activities during DB set- up, Study Maintenance and Database Lock. Review of metrics to determine risks and risk mitigation plans as required • Effectively communicate to and manage internal project teams, external customers and third party vendors • Perform role of SME for Data Management on Partnership Account

Data Management, Early Phase • Setup and review of study documents (e.g. Protocol, Data Management Plan, Data Validation Specification, Case Report Forms, Protocol Deviation Specification, etc.) • User acceptance testing on study database setups and edit checks • Conduct data cleaning (manually and automatically) and query generation • Perform medical coding and SAE reconciliation • Development of project-specific status reports

Data Management, Early Phase • Assisting Project Leads in Early Phase Clinical Trials • User acceptance testing of edit checks • Conduct data cleaning (manually or automatically) and query generation

International Office • Database management, data entry and quality control • Organization of meetings and events • Supervision and support of international students

Pharmaceutical Department, Early Phase • Conduct formulation development and stability test • Preparation of samples for pre-clinical use • Commission and optimization of a modified pipetting robot

Pharmaceutical Department, Early Phase • Assembly and commission of a modified pipetting robot

Specialisation: Biophysical and Biological Chemistry Topic of thesis: Heterologous Production of the Secondary Metabolite Beauvericin in Aspergillus niger

Topic of thesis: Automated formulation development with the pipetting robot platform Lissy and subsequent HPLC analysis