Recent activities covered the following:
Quality Management System /
- Quality Improvement project in a Dutch hospital, to improve and implement an adequate Quality Management System for Clinical Research also covering the required monitor procedures for clinical trials.
- Interim Quality Assurance Manager at a Phase I CRO
- SOP revision for a Medical Device company.
- Performing internal audits on study processes and assessing the completeness of the related study files for a Top-10 pharmaceutical company.
- Internal auditor of company processes at a phase I CRO.
Training GCP / SOP
- Customized GCP training for medical writers and data managers.
- GCP training for a CRO.
- In-company SOP training.
Inge van Gasteren has been involved in various positions in the clinical research industry during the last 23 years.
- 2011 - current Director IGQC
- 2007 - Associate Director Clinical Development at an int. pharmaceutical company
- 2005 - Clinical Research Manager at an international pharmaceutical company
- 2004 - Project Manager Clinical Operations at a medical device CRO
- 2003 - International Clinical Research Associate
- 1992 – Clinical Research Associate for several CRO’s and pharmaceutical companies
For more detailed information, please download my CV.