Clinical Data Associate III – Min 2 years of previous data management exp

Role Overview

• Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s)
• Reviews and adheres to the requirements of study-specific Clinical Data Management Plans
• Creates and enters test data for User Acceptance Testing (UAT)
• Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings
• Receives and enters lab normal ranges
• Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets
• Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database
• Resolves answered queries and requeries where appropriate
• For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs)
• Submits copies of the DCFs to sponsors as necessary
• For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs
• For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable electronic data capture (EDC) systems
• Participates in internal meetings and internal/external audits as required
• Maintains proficiency in Data Management systems and processes through regular trainings
• Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs
• Coordinates the work of CDAs assigned to the project
• Provides training on data management activities and systems
• Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects
• Runs data cleaning and/or status reports

Requirements

• Min 2 years of previous data management experience

Benefits

• We are passionate about developing our people, through career development and progression
• supportive and engaged line management
• technical and therapeutic area training
• peer recognition and total rewards program
• We are committed to building an inclusive culture – where you can authentically be yourself