As below. Expected end date is 31 Jan 2014.

I e.g. updated local procedural documents, conducted quality & compliance reviews, created oversight plans, attended audits and inspections, was responsible for corrective action plans and their implementation, trained the Nordic trial team, helped in trial initiation with documents and submissions, performed accompanied site visits, created or approved the local templates, reviewed the compliance of the electronic files, identified the root causes of the risks and developed and implemented corrective actions as well as reported about these risks to the local upper management team and European Q&C leaders. Experience on four inspections: Fimea (in Finland), FDA (in Sweden) and NoMa (two inspections in Norway).

I performed on site quality monitoring visits, re-monitoring visits, created in a team a checklist for archiving vendor audits,performed local medical depot audits and did different type of quality reviews.

In the role of Local Trial Manager I was responsible for study start up activities including site selection, local document creations (e.g. ICF) and EC and CA submissions. I reviewed all the monitoring reports, was responsible for the local study budget and study milestones. I also always had 2-3 sites which I monitored.