The Clinical Data Manager (DM) ensures that the right information is collected during a clinical trial and that data is accurate. This is achieved through careful design of the data collection tools, methodology for interrogating the data and close liaison with the other study management functions.
Duties and Responsibilities:
- Develop the study database according to the protocol and the contract
- Design the Case Report Form
- Support the department development of documentation and process improvement:
- Write or contribute to preparation of key plans, working instructions, guidelines for the department
- Write or contribute to preparation of study protocol, informed consent forms and clinical research documents
- File study documents in the trial master file
- Provide input into Clinical Data Management System requirements, assuring protocol and/or contract requirements are met
- Collect data generated during the study
- Implement risk management strategies and contingency plans for clinical study deliverables
- Share data management status and issues with the study team
- Ensure studies are carried out according to the study protocol, SOPs, and ICH GCP regulations and study specific manuals and procedures
- Prepare/clean data for analyses.