Description
The job responsibilities will include:- Thorough understanding of Clinical Data Management tasks and assigned protocol(s) with ability to critically evaluate the information in relation to other key project documents and processes.
- Coordinate, create and maintain the Data Management Plan, creation of CRF Guidelines
- Ensure assigned actions are completed within the required time frame.
- Review and approve post production change control study documentation.
- Maintain all data management study documents in the designated TrialShare area and PMF as required.
- Contribute to the development and/or revision of Clinical Data Management SOPs and related documentation
- Gather and consolidate feedback, metrics and status reports from CDM Team Leads to assess CDA performance and quality of deliverables. Escalate any performance and quality issues to PDM.
- Present CDM function at conferences and external non-study meetings.
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