As the number of rare disease patients is small by definition, there is a pressing need for the joint analysis of patient data on natural disease history, genetic makeup, disease modifiers and treatment outcomes. However, the available data is fragmented across different care providers, registries, and countries, and cannot be used to their full potential because data get lost, are not associated with descriptive metadata, or miss essential details on the way they are produced.

We took important first steps in the development of interoperable patient registries, based on the FAIR principles, facilitating joint analysis of patient data from multiple registries. In order to implement the ERN Core Services, including the Clinical Patient Management System and to help in particular with VASCERN's Registry projects, we are looking for an ambitious DATA STEWARD based in Radboudumc, Nijmegen, The Netherlands.

The successful candidate will work in a stimulating medical environment with a European dimension, and will actively participate in an international network of experts who collaborate on best data stewarding practices for rare disease data. The chosen candidate will work daily in close collaboration with the VASCERN Registry WG Chair, Prof. Leo Schultze Kool, The Vascern office in Paris (head Vascern Prof. G Jondeau and clinicians from our HCP members responsible for the registry projects, local administrative and medical representatives, and the local clinical research unit (URC).

Tasks and responsibilities

• Design and implementation of rare disease registries / databases based on the list of items selected by clinicians.
• Engaging with VASCERN registry users (clinicians, data stewards from the HCP members) (this may involve travel to HCP members in Europe).
• Cooperate with other ERNs, European registry initiatives, and rare disease FAIR data experts, in order to make VASCERN registries follow the « FAIR » principles (Findable, Accessible, Interoperable, Reusable, for humans and computers).
• Become trained and familiar with FAIR via tutorial sessions.
• Ensure links with the already existing VASCERN registries and the Rare Diseases Platform (European Union's initiative).
• Participate in, provide assistance, and report on FAIR data stewardship developments, to the VASCERN Registry-WG in virtual and face-to-face meetings.
• Represent VASCERN during specific events associated with Rare Diseases registries.
• Report to the VASCERN project manager on the implementation of the registry projects.
• Provide helpdesk services for the CPMS and registry users.
• Registry management, including drafting of data validation and data management plans.
• Development of strategies for and subsequent coordination of the following tasks:
  • Data monitoring with medical teams, including preparation of data review meetings.
  • Quality control, including control of data / information consistency and compliance with database architecture and FAIR data stewardship practices.
  • Design and drafting of technical documents.
  • Development and implementation of the technical architecture of the servers and databases.
  • Automation of procedures (defining requirements, development and deployment of tools).
• System monitoring and maintenance.

• Academic title (MSc or PhD) in a relevant discipline (data management, data science, biology, bioinformatics, computer science, artificial intelligence).
• Very good writing and verbal communication skills in English. Mastering French or any other EU language is an asset.
• 2 to 5 years' work experience as a Data Manager, previous experience in a medical environment is an asset.

Must-haves:

• Previous experience working in an interdisciplinary environment (clinicians, data managers).
• Capacity to develop and communicate scenarios/ solutions to problems within his/her field of expertise.
• Ability to understand the needs of the clinicians/patients.
• Ability to write and format notes, documents and/or reports related to his/her area of expertise.
• Capability to work as a team and in a larger networks of experts.
• Ability to participate in international meetings, with knowledge on how to explain concepts to clinicians.
• Knowledge of databases and the development or improvement of software applications.

Should have or must have affinity with:

• Surveillance of the systems: identify and diagnose dysfunction or anomalies, materials defects or equipment needs, specific to its field of activity.
• Familiarity with programming and the different IT environments.
• Computer Data Law, Information Privacy protection and the EU General Data Protection Regulation.
• Medical ethics and professional conduct.
• Software dedicated to clinical research (RedCap, CASTOR).
• Database design and update strategies, preferably in the context of health care registries (basic understanding).
• The field of rare diseases, medical vocabulary, interest in clinical and research activities.
• Knowledge in OpenRefine, Microspft Access, MySQL, RDF, medical ontology and genetics welcome.

Fixed-term contract: One year with possible extension.

Upon commencement of employment we require a certificate of conduct (Verklaring Omtrent het Gedrag, VOG) and there will be, depending on the type of job, a screening based on the provided cv. Radboud university medical center's HR Department will apply for this certificate on your behalf.

Read more about the Radboudumc employment conditions and what our International Office can do for you when moving to the Netherlands.

Radboudumc

Department of Radiology and Nuclear Medicine
The Department of Radiology and Nuclear Medicine plays a leading role in intervention radiology. Prof. Schultze Kool plays a leading role in the European Reference Network on Rare Multisystemic Vascular Diseases (VASCERN) and is a recognized expert in the multidisciplinary treatment of vascular malformations. In addition, he is setting up a European, multi-center registry on rare vascular malformation, following the FAIR principles.

Centre for Molecular and Biomolecular Informatics
The Centre for Molecular and Biomolecular Informatics (CMBI) develops bioinformatics approaches that contribute to the understanding of disease mechanisms, personalized therapies and interventions, and a learning health care system. The CMBI is committed to the reusability of their data, tools, and services, and puts the FAIR (Findable, Accessible, Interpretable, Reusable) data principles into action.

VASCERN
In March 2017, the European Commission launched 24 European Reference Networks for rare diseases (ERNs - European Reference Networks for rare diseases, video presentation here). The aim is to facilitate and improve the care of rare disease patients in Europe by uniting European experts in order to share expertise, discuss complex clinical cases through telemedicine and teleexpertise, draft European clinical recommendations, launch new collaborative scientific research projects, develop training and education tools (eLearning), develop EU registries for rare diseases, disseminate knowledge and raise awareness. VASCERN is a 5-years project, which receives co-funding from the 3rd European Union Health Programme and from the EU Connecting Europe Facility (CEF) Programme for its eHealth technologies (ERN Core Services).

VASCERN has 30 Healthcare Providers (expert Centres / specialised units of European Hospitals) in 11 Member States of the European Union, and many patient organisations from all over Europe. The network will expand to new EU countries in the upcoming years. It is structured along 5 Rare Disease Working Groups, transversal working groups (eHealth/ Training & Education, Registry), and the European Patient Advocacy Group (ePAG) gathering patient advocates.

For more information see the websites below:
https://www.radboudumc.nl/en/people/peter-bram-t-hoen
https://vascern.eu/

Radboudumc
Radboudumc strives to be a leading developer of sustainable, innovative and affordable healthcare to improve the health and wellbeing of people and society in the Netherlands and beyond. This is the core of our mission: To have a significant impact on healthcare. To get a better picture of what this entails, check out our strategy.

Read more about what it means to work at Radboudumc and how you can do your part.