Clinical Data Associate

Assists with reviewing and processing Data Clarification Forms, reviewing data listings and quality control reports and updating clinical databases. Assists with Data Entry and Reconciliation as needed or assigned. Assists with start-up activities including Creation and entry of test data for data entry screen validation Set up of patient and investigator information For specified projects assists on some data management activities as detailed below and performs activities in accordance with our SOPs, Good Clinical Practice, ICH Guidelines and study documentation. Study status tracking Data Entry Review of data listings Identification of data issues and query generation Updating of database with query resolutions (on paper studies only) Archiving of critical documents on an ongoing basis Assists with maintaining and updating Data Management Plans and any other relevant Data Management Documentation. Participates in assigned study finalization activities including Database close-out Reconciliation Critical item review Quality Control Archiving. Participation in appropriate project team meetings. Manages time in accordance with allocated hours for task. Participates in departmental and organisational meetings and initiatives