Clinical Data Manager

9/2013 – 12/2014

• Basic Knowledge and Understanding of the Study Design, Protocol, Clinical Trial and Clinical data management activities
• Thorough knowledge of regulatory guidelines like ICH E6 GCP Guidelines.
• Have extensive exposure to CDM databases like RAVE 5.6.4, Oracle Clinical and LSH
• Experience in retrieving reports in Spot Fire.
• Can create and run simple programs in j-review / i-review
• SharePoint Management and document maintenance
• Have worked in 10 studies independently till date and have contributed for DB lock and Interim Timelines.
• Exposure towards different therapeutic area such as Immunology, Oncology, Virology, Endocrinology etc.
• Have contributed in creation of Training Materials and templates for the Team. Also have involved myself in training the new comers to the team with regards to process and applications.

Oracle-Anwendungen, Microsoft SharePoint Server, BASIC (Beginner’s All-purpose Symbolic Instruction Code), Schulung / Training (IT), Installation / Montage / Wartung (allg.), FireCAN, CAN-Bus (controller area network), Management (allg.), Datenmanagement, Öffentlichkeitsarbeit, Design (allg.), Indesign, Medizinforschung, Klinische Forschung