Heike Kurzdim

Senior Clinical Research Manager

Spergauer Str. 39
D-06688 Weißenfels
Phone: +49 34446-349 333
Fax: +49 34446-349 331
Mobil: +49 176 5698 1896

heike.kurzidim@cra-freelance.net

Born in Löbau 02.10.1968

 

Professional experience

13 years of experience in international clinical research of Phase I-IV in combination with the performance of studies according to various standards, including the European GCP guidelines Indications: Cardiology, Dermatology, Diabetology, Gastroenterology, Gynaecology, Nephrology, Neurology, Oncology, Paediatrics, Pulmology, Urology

Employments

  • 1987 – 1988 Employed as laboratory technician in Neubrandenburg
  • 1989 – 1994 University of Magdeburg / Köthen, Subject: biotechnology
  • 1994 – 1996 Employed as qualified engineer outside the office for environmental technology
  • 1996 – 1999 Innovex Biodesign GmbH, Clinical Trial Monitor
  • 1999 – 2002 AMS GmbH, CRA and Project Manager
  • 2002 – 2007 Faustus Forschungs Cie., Clinical Research Manager
  • Since 2007 Freelancer for different pharmaceutical companies

Professional training

  • 1996 Training as CTM according to GCP guidelines at Innovex
  • 1996 Excel-Training
  • 1996 Communication Training
  • 1997 Innovex 2000 Quality Training
  • 1997 Word-Training
  • 1997 PC-Training
  • 1997 Business-Englis
  • 1997 Laboratory Data
  • 1997 ICH-GCP
  • 1997 Time Management
  • 1998 ECG-Training
  • 1998 Lotus Notes Training
  • 1998 Ethic committee and approval
  • 2001 SOP Training
  • 2002 Laboratory Training
  • 2002 Business- English
  • 2002 Drugs in oncology
  • 2002 Methodology of clinical research in oncology
  • 2003 MS Project
  • 2003 Adobe Page Maker
  • 2003 Oncology
  • 2004 Effective Pharmacovigilance
  • 2005 SOP Training
  • 2006 AMG/ EMEA – new guidelines
  • 2007 GCP/ ICH – new guidelines in Europe and US
  • 2007 Training eCRF
  • 2007 SOP-Training
  • 2008 Development paediatric clinical trials
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