Do you have a scientific background and a specific interest for managing research data? Are you computer literate or do you have programming skills? Then check out the below, we are actively looking for enthusiastic Clinical Data Managers, motivated and eager to dive in and further explore the world of Clinical Research Data.
The Clinical Data Manager is responsible for all the steps required for the setup of the Data Management tools of a clinical trial. He/She is responsible 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.
Clinical trial protocol:
- You develop Data Management sections of the clinical trial protocol
- You define the visit schedule
- You assist in final review of the clinical trial protocol for consistency
Case Report Forms:
- You develop Case Report Forms in accordance with the protocol and the database
- You define Case Report Forms specifications
- You develop guidelines for Case Report Forms completion
- You coordinate control data collection, data cleaning and data reporting activities
- You apply QC to each stage in the data handling to ensure the data are reliable and processed in compliance with ICH-GCP requirements.
- You communicate with the participating investigators in order to resolve queries and collect missing data
- You perform the reconciliation of SAEs with the clinical database
- You develop and do the maintenance of the data management plans for the studies
- You develop edit checks specifications
- You prepare and attend medical review meetings with the Clinical Research Physician
- You prepare bi-annual Group Members newsletters on the studies under your responsibility
- You file all study related documents, in compliance with ICH-GCP requirements
- You have a background in Life Sciences (Bachelor or Master degree)
- You have a first experience in data entry, data reviewing or data cleaning (internship or working experience)
- You are computer literate or you have programming skills
- You are fluent in English and in French or Dutch
- You have good organizational & administrative skills
- You are rigorous, attached to details
- You have excellent analytical skills
- You have the existing right to work in Europe
- A balanced salary package based on your capabilities and experience.
Vacancy number: 18828