We are looking for an experienced and accurate clinical manager at the Research Team of the White Health Ambassador Company to help us record and manage clinical data in clinical studies on a modern medical device. This person will play a key role in designing systematic data registration protocols, designing testing, adapting to international standards (FDA/CE) and data quality management. If one has significant abilities, it is possible to increase the contract amount.
Tasks:
• Data Protocol Design and CRF Forms (Case Report Form) in accordance with scientific and legal standards
• General Management of Data Registration, Storage and Cleansing
• Production of Standard Documentation such as DMP (DMP). Operators and Data Analysts
• Guarantee GCP (Good Clinical Practice), CDISC and HIPAA
• Introduction to CE and FDA
Essential Skills:
1. Experience and Knowledge of Specialized
• A history of medical data management in clinical studies (Clinical Trials/ObServational Studies)
• Study Protocol Design Experience and Data Registration Forms (CRFS)
• Introduction to EDC (Electronic Data Capture), such as Redcap or Opticalinica
CDISC (Clinical Data Interchange Standards Consortium), GCP (Good Clinical Practice) and HIPAA
• Ability to produce and manage Data Management Plan (DMP)
• Data Quality Control (Data Cleaning / Query Resolution)
With clinical data
2. Software skills
• Mastery of Excel, SPSS or R or Python software for initial data analysis
• Database (SQL), EDC systems and data monitoring tools
3. Individual and Organizational Ability
• High accuracy and attention to details
• Ability to manage data registration teams or interact with operators and doctors
• Skills to write scientific and legal reports for data
• Ability to educate others in the field of correct and structured data
Scientific prerequisite:
The worker can be a physician, a statistics specialist, and so on. Experience and experience in clinical data recordings are our top priority.