Roles and Responsibilities:
This is a unique opportunity for a motivated and experienced individual who wishes to further develop his/her career in clinical research data management and multinational research projects.
The ECRIN Clinical Research Data Expert will participate in the planning, modelling, design, implementation, testing and documentation of tools and services including IT solutions, supporting clinical research. In particular, he/she will act as the technical representative of ECRIN in projects. This includes participation in projects on data management in multi-arm trials, cohort integration, multimodal data management, data sharing and secondary use of health data, as well as in the ECRIN Data Centre Certification Programme and standards development. Training others on these and related topics, such as data standards, may also be required.
The Data Expert works with the ECRIN core team based in Paris, as part of the Infrastructure Development Unit and reports to the Unit Head
Requirements (education, knowledge and skills):
- MSc level, scientific background (biomedical sciences, computer science, or mathematics, physics, biology)
- Extensive knowledge of data management in clinical trials and observational studies, including multimodal data management
- Knowledge of regulatory and data protection challenges, in particular in the context of the secondary use of sensitive health data and the management of data repositories.
- Knowledge of modern IT architectures, including web-based technologies, especially as they relate to clinical data research management
- Experience in developing, testing, and documenting software projects
- Ability to interact positively with a wide range of organisations and professionals
- Strong oral and written communication skills
- Excellent written and spoken English (working language)
- A dedicated yet diplomatic personality
Recommended knowledge and skills:
- Familiarity with standards in clinical research projects (especially but not exclusively CDISC) and metadata standards in scientific research
- Knowledge of data management related to submission to regulatory authorities:
- Application of CDASH and other standards to data design
- Knowledge of SDTM / define.xml and ability to support their use
- Awareness of the increased validation and inspection burden that a submission process may bring
- Ability to support data sharing, e.g. by de-identification measures and transformation into more standardised forms
- Knowledge of the use of data standards in routine healthcare to promote research
- Experience of liaison with standards organisations
- Experience in project management
- Experience in operating at the European/international level
- Experience in a training role.
The post is a full-time contract according to French law. The salary is set according to European/international standards for similar positions, and will depend on qualifications and experience. A relocation package may be included.
Place of employment: Paris, France, where ECRIN has its Management Office and legal address.
A letter of motivation with a Curriculum Vitae (European format with photo) may be addressed to Mrs Alicja Szofer-Araya (firstname.lastname@example.org).
Deadline to receive applications: 31 March 2021
Expected start date: May 2021
ECRIN is an inclusive, equal opportunity and non-discrimination employer offering attractive conditions and benefits appropriate to an international research organisation.
More information on ECRIN at www.ecrin.org