The Clinical Data Manager is responsible for the collection and processing of all the relevant information required for the set up of a clinical trial / cleaning of the data / reporting to the group.
The Clinical Data Manager works under the hierarchal supervision of the Head of the Data Management Department.
The Clinical Data Manager reports on his/her activities and status of the study to the Clinical Research Physician, Statistician & Project Manager.
Clinical Trial Management
Those tasks will be carried out by the Clinical Data Manager with the close coaching of a Lead Data Manager:
Clinical trial protocol
- Development of the Data Management sections of the clinical trial protocol
- Assisting in final review of the clinical trial protocol for consistency
- Definition & creation of the study protocol in the database
Case Report Forms
- Development of the Case Report Forms in accordance with the protocol and the database
- Development of the guidelines for Case Report Forms completion
- Coordination and control of data collection, data cleaning and data reporting activities
- Application of QC to each stage in the data handling to ensure the data are reliable and processed in compliance with ICH-GCP requirements
- Communication with the participating investigators in order to resolve queries and collect missing data
- Conduct of the reconciliation of SAEs
- Development and maintenance of data validation plans for the studies
- Development of crosschecks and validation checks programs
- Preparation of and attendance to the medical review meetings with the Clinical Research Physician
- Preparation of bi-annual Group Members reports on the studies under her/his responsibility
- Proper filing of all study related documents, in compliance with ICH-GCP requirements