Find a Meaningful Job at Eortc

il y a 4 semaines


Brussels, Belgique EORTC Temps plein

The Clinical Data Manager works under the hierarchal supervision of the Clinical Data Expert. The Clinical Data Manager reports on his/her activities and status of the study 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 in a timely manner; this is to ensure adequacy, integrity and quality of the data that are used to answer the questions of our studies.

**Clinical Trial Management**:
The Clinical Data Manager will carry out those tasks with the close coaching of a Clinical Data Expert:

- 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 consistency and compliance with the EORTC Global Library for Case Report Forms
- Case Report Forms
- Development and definition of the study-specific Case Report Forms in accordance with the protocol and the database
- Development of the guidelines for Case Report Forms Completion
- Database Design and Validation
- Definition of the requirements for database design by the Study Designer
- Development of the test plan and user tests for database validation
- Execution of user tests regarding the database validation
- 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 in order 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 plans for the studies
- Preparation and attendance of the medical review meetings with the Clinical Research Physician

**Other**:

- Preparation of bi-annual EORTC Group Members newsletters on the studies under her/his responsibility
- 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 organizational & administrative skills
- Rigorous, attached to details
- Excellent analytical skills
- Team spirit
- English is very good (written & spoken), French and Dutch are assets

**Benefits**:

- 30 days holidays- Competitive Salary Package- DKV Hospitalization insurance- Free parking- Hybrid working environment- Full reimbursement public transport- Meal vouchers- Pension plan- Permanent contract- Homeworking allowance



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