2009 - maintenantCoordination of an international phase I to IV clinical trials including:
- management of outsourcing (CRO, laboratory)
- management of financial aspects
- evaluation of human resources
- quality control of clinical trials
HRA Pharma
- Clinical Quality Officer
2007 - maintenant- In charge of the quality of the R&D department including writing, validation of SOPs as well as , training of R&D staff to SOPs
- Preparation of audits and inspections
HRA Pharma
- Clinical Research Assistant
2006 - 2008- Monitoring of international phase I, II and II clinical trials in Women's health
- Role in a phase III study including investigator’s meeting, initiation visits, monitoring in the UK (9 sites)
- CRAs training for outsourcing (US)
- Set up of monitoring tools
- Use of eCRF
- Initiation, monitoring and close-out visits of several phase I clinical trials (bioavailability and pharmacokinetic studies) including protocol writing, partnership selection
- monitoring of a phase II clinical trial
