"Do you have a Bachelor/Master degree in a health-related or scientific discipline? Do you have a first experience in data monitoring and/or reviewing? And you are fluent in English. Then we may have your dream job!"
The Clinical Data Manager works under the hierarchical supervision of the Clinical Data Expert. The Clinical Data Manager reports on his/her activities and status of the study to the study team.
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 to ensure adequacy, integrity and quality of the data that are used to answer the questions of our studies.
Clinical trial protocol:
Development of the Data Management sections of the clinical trial protocol
Defining the visit schedule
Assisting in final review of the clinical trial protocol for consistency
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 Group Members newsletters on the studies under her/his responsibility
Proper filing of all study related documents, in compliance with ICH-GCP requirements
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
English very good (written & spoken), French & Dutch are assets
A balanced salary package based on your capabilities and experience, including meal vouchers
Full time position, under direct contract of our client
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 17681