RESPONSIBILITIES

• Participate in the development of Case Report Forms (CRFs) for use by the DataFax system or other EDC systems using Adobe FrameMaker
• Responsible for setting up and testing the DataFax databases including programming and testing custom edit checks/automatic queries and annotation of the CRFs (UAT)
• Generate study QA/QC plan using DataFax's level system
• Manage and trains other staff hired to the DataFax data management unit in various field sites and coordinates data entry and QA/QC activities either remotely or in person
• Provide training to field teams on proper completion of CRF forms as related to DataFax requirements either remotely or in person
• Perform regular QA/QC audits of database which include validating data entered into system, providing constructive feedback to field teams regarding data entry, reviews automatically and manually generated queries, generates regular QC reports for field teams containing errors and inconsistencies on CRFs for correction

REQUIREMENTS

• Datafax experience
• Relational database management knowledge
• Strong computer skills: knowledge of computer programs and programming normally used for data capture, retrieval and analysis: Clinical DataFax, DataFax Edit Check programming, and Adobe FrameMaker, Proficiency with SQL and relational databases, Visual Basic Programming, SAS Base programming
• Knowledge of Good Clinical Data Management Practices, clinical trial processes and Data quality management
• Knowledge of ICH Guidelines and GCP for the conduct of clinical research, especially as related to data handling and processing
• Attention to detail, especially regarding data accuracy
• Team building and management skills

HOW TO APPLY