The Clinical Data Manager works under the hierarchical supervision of the Clinical Data Expert. The Clinical Data Manager reports on study activities and status to the study team.
Main responsibilities / Major Activities
The Clinical Data Manager is 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 promptly; this is to ensure the adequacy, integrity and quality of the data that are used to answer the questions of our studies. The Clinical Data Manager will carry out the following tasks, with the close coaching of a Clinical Data Expert:
Clinical trial protocol
- Development of the Data Management sections of the clinical trial protocol
- Assisting in the final review of the clinical trial protocol for consistency and operational feasibility
Case Report Forms
- Development and definition of the study-specific Case Report Forms following the protocol and the EORTC Global Library
- Development of the guidelines for Case Report Forms Completion
Database Design and Validation
- Definition of the requirements for database design by the Study Designer
- Defining the visit schedule
- Development of the test plan and user tests for database validation
- Coordination of user tests regarding database validation
- Can perform the activities of a Study Designer as needed
Data handling
- 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 to resolve queries and collect missing data
- Performing the reconciliation of SAEs with the clinical database when applicable
Other
- Development and maintenance of the data management plan
- Preparation and attendance of the medical review meetings with the Medical Representative
- Contribution to EORTC Group Members newsletters
- Proper filing of all study-related documents, in compliance with ICH-GCP requirements
Profile
- Professional bachelor’s or master’s degree in a health-related or scientific discipline
- Computer literate: programming skills as well as skills in the use and management of computer databases are strong assets
- Knowledge of CDISC standards preferred, SDTM in particular
- Experience in data monitoring and/or reviewing is an asset
- Good organisational & administrative skills
- Rigorous, attached to details
- Excellent analytical skills
- Team spirit
- English very good (written & spoken), French & Dutch are assets
Benefits
Permanent contract
Wage according to our Non-Profit organisation status
Hybrid working environment (from Belgium)
30 days holidays (full time)
Meal vouchers
Pension plan
Hospitalisation insurance and ambulatory care
Homeworking allowance
Reimbursement of public transport
Free parking
