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Clinical Data Manager Career Profile
Clinical Data Management is concerned with the processing of incoming clinical trial data from ongoing trials and the analysis and organisation of the data in preparation for registration with the regulatory bodies, e.g. the Irish Medicines Board (IMB) or the US Food and Drug Administration (FDA).
The main entry level position in data management is the Clinical Data Coordinator and this position generally requires a good degree in life sciences or mathematics and a high competency in analytical and organisational skills.
- Migrate / deliver high quality data for specified protocols within agreed timeframes to achieve prompt submissions/publication of results
- Write project procedures and guidelines for effective data capture and review in collaboration with clinical monitors
- Ensure the quality of project data by developing and applying comprehensive validation procedures prior to the migration of data
- Implement production databases at the start of each project to enable data cleaning to occur at an early stage; co-ordinate the design of record forms/screens for studies.
- Communicate effectively with International Project team, and Corporate Computing Support
- Provide training and support for Hospital Investigators and Study Staff; communicate effectively with investigational sites to resolve data clean-up queries
- Maintain systems to track the data management process
- Develop and maintain project data management plans and co-ordinate the activities of informal project data management teams comprising Clinical Research Officer(s), Data Entry, Data Analyst and external Contract Research Organisation staff to ensure adherence to agreed schedules