Dr. rer. nat. Thomas Lanz
Birkenweg 17
D-29456 Hitzacker
Phone: +49 5862 3389999
Fax: +49 5862 3389997
Mobile: +49 162 2482013
E-Mail: thomas.lanz@cra-freelance.net
DoB: 1956
Experience
Familiar with clinical research processes since 1992, self employed since 2004. Currently working as Freelance CRA in Clinical Research:
- Monitoring of clinical studies on site and remotely (centralized
monitoring) in various indications e.g. Anesthesiology, Dermatology,
Cardio Vascular Diseases, Diabetes, Oncology, Infection, Immunology,
Pulmonary Disease, premature infants, Histopathology Laboratory - Co-monitoring visits with CRAs and CSMs
- Review of Monitoring Visit Reports and Clinical Study Report
- Investigational Site Audit in European Countries
Previous career as employee in the pharmaceutical industry:
Director Clincial Monitoring
- Post – merger integration of the monitoring – departments of Astra and Zeneca
- Organization home-based CRA structure (29 CRAs)
- Establishment of regional organization and coaching
- Performance measurement, bench-marking
- Quality control
- Resource planning, Budget
- Co-operation with freelance CRAs
- Establishment of process for selection and quality control of CROs
- Contracts with CROs and freelance CRAs
Line Manager Data Management
- Establishment and maintenance a local data-management department. Implementation the global data-management system
- Data-management for local and global trials
- Participation in the global steering group for the data management system and processes
Project Manager
- Project management of International multicenter-trials in hypertension, heart rhythm disturbances and cardio-vascular events (outcome trial). Trials in infection with HIV-patients and patients with CMV infection after bone marrow transplantation. Management of study teams with 2- 6 members. Main contact person to international study team.
CRA
- Monitoring of Clinical Studies
- Maintenance of Study Master File
- Support / Training of Investigators and study site personnel
Employments
- 1991 Post Doc University Freiburg and Giessen
- 1992 – 1993 Clinical Research Associate, Biodesign (Innovex) GmbH, Freiburg
- 1994 – 2004 CRA, Study Co-ordinator, Line Manager Data Management, GCP-Manager, Director Clinical Monitoring at AstraZeneca GmbH, Germany
- Since 2004 Self employed, own company Iris Management GmbH
Education / Qualification
- 1975 High School leaving exam in Geislingen/Steige
- 1975 – 1976 Studies of Law, University Tübingen
- 1979 – 1982 Studies of Psychology, University Bamberg
- 1982 – 1988 Studies of Biology, University Freiburg
- 1988 – 1991 Thesis, University Freiburg; PhD (Dr. rer. nat.)
Since 1992 – Continuous qualification in processes of clinical research as clinical research associate, projectmanager and line manager at contract research organisation and pharmaceutical companies. For details see training record.
