Magdalena Woźniak

Performing all tasks relating to data management from the start to the finish of a study:
• defining Database Build specification and test database;
• assisting in the testing of databases prior to activation;
• creating study specific documentation;
• assisting with the processing of clinical data for projects;
• supervising the study specific Data Entry Team;
• critically review CRFs as specified in the study specific DMP and to query and resolve any errors/quires as required;
• assisting with the coding of adverse events, medical history and medications;
• performing SAE reconciliation for EDC study
• performing the Quality Control of Data Entry;
• preparing any documentation for return at study completion;
• reporting study progress against schedules to management and client

Study Base Set Up
• To assist in the database construction and testing thereof
• To assist in the preparation of study specific documentation as appropriate
Management of CRFs for allocated projects
• To assist in the management of tracking and log-in of CRFs
• To maintain a stable electronic CRF management system. Receive CRFs and record their movement in an electronic CRF management system.
• To enter/edit data from CRFs into the study database.
• Archiving CRFs/Transit of CRF for translation/ back to clients.
Review of CRFs for allocated projects
• To resolve Self-Evident Queries/Allowable Changes in the study specific Database
• To track and resolve Data Clarification Forms in the study specific Database
• To assist with the Quality Control of Data Entry and CRF/database as appropriate
• To assist study specific Lead Data Managers preparation of status report for clients
To perform other reasonable tasks as requested by management

• administration of magazine
• controlling magazine conditions in computer system and comparing it with actual state
• entering data into data base
• supervising work of magazine