Karine I.

I have 5 years experience as a clinical data manager. While working as a Data Manager in an International company I have gained much experience not only in database field but also gained valuable experience acquiring strong leadership and interpersonal skills which I think can be successfully applied in further collaboration. Dealing with the diverse concerns and situations I have become adept at operating with the proper mix of authority, diplomacy, and tact. I am able to think quickly in emergency situations and in those requiring quick assessment of many factors in order to make appropriate decisions concerning both conducting the database process and he current issues coming up within a working group. Responsible for discrepancy management and DCF processing of clinical trials databases. Commonly perform the following data related activities: discrepancy Management, Current Report Review, Procedure Testing, Completion Guidelines Development, DCF creation, DCF resolution, and database updates. Provides accurate, timely, and consistent review of discrepancies to study sponsors and other internal clients to support the study timelines, contributing to the design of protocols, which define what and when data are to be collected; designing and approving forms on which data are collected; designing databases and ensuring they meet requirements for the entry and reporting of clinical data; training clinical research associates to help improve the quality of the data being collected; producing summaries and listings of safety and efficacy data; testing new processes and systems for the management of clinical trials