Clinical Data Manager - Brussels, België - EORTC

EORTC

Geverifieerd bedrijf

Brussels, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

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