Recent Jobs

Recent activities covered the following:

• Quality Improvement project in various Dutch hospitals, to improve and implement an adequate Quality Management System for conducting clinical trials and Investigator Initiated Trials.
• QA Manager at Biotech companies, Data Management/Pharmacovigilance CRO, Phase I CRO, interim QA Manager at a top-10 Pharmaceutical company.
• SOP revisions for Medical Device companies.

• Full service CRO qualification audits and compliance audits.
• Vendor audits ((e.g. Pharmacovigilance, Data Management, Laboratory, computerized system audits).

• 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.

• Customized GCP training for medical writers and data managers.
• GCP training for a CRO.
• In-company SOP training.

Curriculum Vitae

Inge van Gasteren has been involved in various positions in the clinical research industry during the last 30 years.

In Summary:

• 2011 - Managing Director IGQC B.V.
• 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 CROs and pharmaceutical companies

For more detailed information, please download my CV.