• support & usage consulting for the Clinical trial management systems & Databases
• Database user responsible for eClinical Technologies, Clinical Trial Management Systems & Databases and Reporting Applications (Microsoft SharePoint, Parexel IMPACT, Perceptive MyTrials, IBM Cognos)
• Development of reporting design specifications, Testing and Validation of GXP relevant Reports and System Upgrades
• Training of new employees and development of Training & Guideline Documents as well as SOPs

• IT support & usage consulting for the Clinical trial management systems & Databases
• Database user responsible for eClinical Technologies, Clinical Trial Management Systems & Databases and Reporting Applications (Microsoft SharePoint, Parexel IMPACT, Perceptive MyTrials, IBM Cognos)
• Development of Design Specifications, Testing and Validation of GXP relevant Reports and System Upgrades
• Training of new employees and development of Training & Guideline Documents as well as SOPs

• Working on non-interventional studies on Huntington’s disease in Germany, Austria and Switzerland
• Remote and onsite monitoring of study sites in Germany, Austria and Switzerland including the preparation and submission phase for ethics submission and regulatory authorities information
• Working on the preparation of study protocols and patient facing materials

• Remote and onsite monitoring and site-management of study sites in Germany
• Site selection, ethics submission, regulatory authorities information, management of central lab and other vendors for sites in Germany
• Presentations on investigator meetings
• Contract contact for site investigators
• Consulting and support of investigators with presentations and with the initial training of new study personal
• training of new employees

• Working on international multi-site clinical studies (Phase IIb
• and III) in Germany
• Remote and onsite monitoring and site-management of study sites in Germany
• Site selection, ethics submission, regulatory authorities information, management of central lab and other vendors for sites in Germany
• Presentations on investigator meetings
• Contract contact for site investigators
• Consulting and support of investigators with presentations and with the initial training of new study personal
• training of new employees
• Indications: 
  • hypertension
  • coronary heart disease
  • heart failure
  • Vaccinations against influenza
  • Type II Diabetes Mellitus
  • Gout
  • Spondylitis ankylosans
  • Psoriatis arthritis
  • Rheumatoid arthritis

• Monitoring and Site-Management for the German sites
• Support of the Investigators on central-lab management
• Audit-Preparation on a selected site, Audit-Report without major or critical findings

• Monitoring and Site-Management for the German sites
• Support of the Investigators on central-lab management
• Audit-Preparation on a selected site, Audit-Report without major or critical findings

Working on a nutritional supplement vaccination study in Germany

• Consulting on study conduction, legal regulations and ICH-GCP
• Monitoring und site management for the sites in Germany