Clinical data specialist/ manager

The Clinical Data Manager works under the hierarchal supervision of the Clinical Data Expert. The Clinical Data Manager reports on his/her activities and status of the study to the study team. The Clinical Data Manager is responsible for all the steps required for the setup of the Data Management tools of a clinical trial and for the collection, review and validation of the clinical data in a timely manner; this to ensure adequacy, integrity and quality of the data that are used to answer the questions of our studies. Those tasks will be carried out by the Clinical Data Manager with the close coaching of a Clinical Data Expert: Clinical trial protocol • Development of the Data Management sections of the clinical trial protocol • Defining the visit schedule • Assisting in final review of the clinical trial protocol for consistency and compliance with the Global Library for Case Report Forms Case Report Forms • Development and definition of the study specific Case Report Forms in accordance with the protocol and the database • Development of the guidelines for Case Report Forms completion Database Design and Validation • Definition of the requirements for database design by the Study Designer • Development of the test plan and user tests for database validation • Execution of user tests regarding the database validation Data handling • Coordination and control of data collection, data cleaning and data reporting activities • Application of QC to each stage in the data handling to ensure the data are reliable and processed in compliance with ICH-GCP requirements. • Communication with the participating investigators in order to resolve queries and collect missing data • Performing the reconciliation of SAEs with the clinical database when applicable Other • Development and maintenance of the data management plans for the studies • Preparation and attendance of the medical review meetings with the Clinical Research Physician