As Clinical Data Manager, you work under the hierarchal supervision of the Clinical Data Expert. You report on your activities and status of the study to the study team.
You are responsible for all the steps required for the setup of the Data Management tools of a clinical trial and for the collection, review and validation of the clinical data in a timely manner; this to ensure adequacy, integrity and quality of the data that are used to answer the questions of the studies.
This include several responsibilities :
Clinical trial protocol
- Development of the Data Management sections of the clinical trial protocol
- Defining the visit schedule
- Assisting in the final review of the clinical trial protocol for consistence
Case Report Forms
- Development of the Case Report Forms in accordance with the protocol and the database
- Definition of the Case Report Forms specifications
- 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
- Performing the reconciliation of SAEs with the clinical database
- Development and maintenance of the data management plans for the studies
- Development of edit checks specifications
- Preparation and attendance of the medical review meetings with the Clinical Research Physician
- Preparation of bi-annual company’s Group Members newsletters on the studies under her/his responsibility
- Proper filing of all study related documents, in compliance with ICH-GCP requirements