Clinical Data Coordinator at Synteract

Position Overview

The Clinical Data Coordinator supports the Clinical Data Manager in delivery of Data Management contracted services on assigned projects. This includes responsibility for tasks and processes associated with database build, data review and closure of the database.

Specific Tasks Would Include

• Reads and follows the Data Management Plan (DMP) for ongoing projects.
• Assists in development of Clinical Data Management Database Systems including QC or testing activities required for database finalization.
• Performs testing on custom reports and listings.
• Assists with development of supporting Data Management documentation as required, including but not limited to: CRF Completion Guidelines, Test Subject Cases and Data Entry Guidelines.
• May perform data entry and/or verification tasks as necessary for assigned projects.
• Conducts Data Management tasks for data review, including production of reports, listing, or other outputs required, authoring/ issuing queries, data reconciliation and query updates.
• Assists the Clinical Data Manager with data review metrics and reporting
• Conducts database maintenance activities, including permissions activities, end user training, and maintenance activities of training records.
• May act as back up support to the Clinical Data Manager for sponsor facing communications as required.
• Exports data from the clinical database to provide either internally or externally.
• Conducts all activities and files documentation in accordance with SOP requirements and TMF filing guidelines.
• Performs final Quality Control check of profiled clinical data against paper CRFs for paper studies.

Qualifications

• Bachelor’s degree in a related field of study or equivalent combination of education and work experience.
• 2 years experience in clinical research preferred.
• Medical terminology exposure preferred.
• Knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
• Transferable skills in a related industry role is an asset.
• Proficiency in Microsoft Word, Excel, and Outlook
• Effective verbal and writing skills; English + local language, if relevant.