BIOCYCLE is hiring a DATA MANAGER
Background:
The European Project – BIOCYCLE (https://www.biocycle.eu), project aims at assessing long-term treatment strategies in Crohn’s disease that will improve both safety and related costs while ensuring a constant level of eficacy during maintenance therapy. In that frame, IBDIM (research department of « European Crohn’s disease and Colitis Organization » – ECCO), one of the partners, is recruiting a data manager.
IBDIM role in the project:
WP 2: Dissemination and exploitation of the results
WP 9: Supporting the entry of BIOCYCLE data in the United Registries for Clinical Assessment and Research platform (UR-CARE – https://www.ecco-ibd.eu/science/ur-care.html) by employing two data manager fellows: one German-speaking data manager, one French/Dutch-speaking data manager
Mission description:
Under the overall authority of the IBDiM Managing Director, Filip Bart, the direct supervision of Edouard Louis (as BIOCYCLE Project Coordinator – Head of the gastroenterology department of CHU de Liège) and Britta Siegmund (on behalf of Charité Berlin as Biocycle Clinical Trial participant and UR-CARE Steering Committee Memner), the IBDiM BIOCYCLE Data Manager will have to entry patients’ data in ECCO UR-CARE database according to predefined selection criteria, in different Belgian (French and Dutch) and possibly French hospitals. He/She will:
- Keep absolute confidentiality of the project work;
- Familiarise themselves in detail with the BIOCYCLE project history, timeline and content;
- Familiarise themselves in detail with WP9 of the BIOCYCLE project history, timeline and content
- Familiarise themselves in detail with the DECIDE part of the WP9 of the BIOCYCLE project history, timeline and content
- Interact with the principal investigators of the country where they are working to have a full explanation and description of the specific tasks they have to fill in (Britta Siegmund for Germany, Gerhard Rogler for Switzerland, Edouard Louis and Filip Baert for Belgium, Javier Gisbert for Spain)
- In each of these countries, identify the list of participating centres and the local investigators
- Familiarize themselves with the UR-CARE database
- Ensure sites compliance with delegation of responsibilities and other GCP requirements regarding access
- Determine with national/local principal investigators a predefined number of patients to encode in a predefined timeline
- Ensure the patient has signed consent before data entry in UR-CARE
- For patients already recorded in UR-CARE: identify in UR-CARE the patients having been treated with an immunomodulator and/or a biologic treatment
- For the patients not yet recorded in UR-CARE database: identify from the center database the patients having been treated with and immunomodulator and/or a biologic treatment
- From the DECIDE project, create a list of variables and data to collect in the UR-CARE database for each of these patients
- From the UR-CARE database (for patients already recorded) or from the local centre database, identify the missing data for the selected patients
- Retrieve these data from the patients notes under the supervision of the local investigator
- Complete the data in UR-CARE for the patients already recorded in it
- Transfer the local centre database data completed by the data from the patients notes to UR-CARE for the patients not yet recorded in UR-CARE
- Regular QC of data to ensure quality of extractions
Requested skills:
- French and Dutch (B2 level minimum)
- English (B1 level)
Contract conditions:
- Starting date: March 2021
- Duration: 7 months, full time
- Location: Liège, Wallonia, Belgium