Dr. rer. nat. Thomas Lanz

Tüschau 13
D-29482 Küsten
Phone: +49 5864 9900
Fax: +49 5864 9901
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.
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