Clinical Research Specialist

5/2004 – offen

Senior CRA, Lead-CRA, Project Management, Study-Start-up, Clinical Monitoring

Conduction and Management of national and international clinical studies in Germany, Austria, Switzerland, Belgium, Norway, Poland and The Netherlands with different therapeutic areas.

Coordination of clinical studies in Europe, US, Canada, Israel, New-Zealand, Australia

Experience in orphan diseases, Cardiology, Endocrinology, Oncology, Gastroenterology, CNS, Immunology/Hematology, Rheumatology, Orthopaedics, Dermatology, Genetic disorder, Pneumology and Vaccine.

EC and Regulatory submission specialist for Germany, Austria and Switzerland -
Pharmaceutical Drugs and Medical Devices

Study stages from start up to close out, phase I - phase IV

Klinische Studie

1/2001 – 4/2004

Senior/Lead-CRA
Coordination of Crohn’s Disease Study - Phase III - Study Management for Europe, US, Canada and Israel
Coordination of Mamma Carcinoma Study - Phase III - Study Management
Coordination of Rheumatoid Arthritis Study - Phase III - Study Management for Europe and USA
Coordination of sleep disorder study - Study Management for Europe
Coordination of epilepsy study - Study Management for Europe

- Lead feasibility assessment and selection
- ICH-GCP training of study team/Investigator
- Lead development of study plans and system set-up; protocol, CRF, ICF and other trial documents (e.g. CRF, Monitoring Guidelines, data cleaning plans, statistical analysis plans, vendor contracts, lab manual, IVRS)
- Oversee clinical aspects of timely data cleaning, data analysis; participate in data reviews
- Ensure appropriate response to new safety information (e.g. update of trial documents).
- Manage and lead cross-functional study teams, including vendors
- Coordination/planning of Investigator Meetings
- Ensure Provide study specific training for internal and external (e.g. vendors, investigators) Team members.
- Mentor and role model for CRAs
- Clinical Monitoring

Klinische Studie

3/1998 – 12/2000

Clinical Research Associate
Conduction of cerebral vascular accident study
Conduction of multiple Trauma with severe hemorrhagic shock
Conduction of PTCA Study - Phase II

Site Management
Clinical Monitoring
EC and CA submission

Klinische Monitor (CRA)