ECRIN is a non-profit, distributed infrastructure. It was awarded the legal status of a European Research Infrastructure Consortium (ERIC) in 2013 based on Council Regulation (EC) N° 723/2009 of 25th June 2009 on the Community legal framework for an ERIC.
ECRIN provides support to the management of multinational clinical research projects in Europe. ECRIN is based on the connection of national networks of clinical research infrastructures (clinical trial units) having the capacity to manage trials locally. ECRIN provides information, consulting and services to investigators and sponsors in the preparation and in the conduct of multinational clinical studies, in any disease area. Most of the ECRIN-supported projects are funded by the Horizon 2020 (H2020) Programme of the European Union or by the Innovative Medicines Initiative (IMI).
The Project Manager is responsible for managing projects that are allocated to him/her, either a clinical study, or the development of a new tool for cutting edge multinational clinical studies, with particular focus on rare diseases
The main duties of the ECRIN Project Manager will include the following :
For clinical studies:
- Coordinating the operational management of ECRIN-supported clinical studies that are assigned to him/her: provision of information, feasibility and risk assessment and organising the provision of distributed, multinational study management services; in particular regulatory and ethical submissions, adverse event reporting, monitoring, data management.
- Ensuring compliance of ECRIN services with the ECRIN quality management policy.
- Working closely with investigators and sponsors to adapt ECRIN services to the context of the study and to the funding available
- Maintaining and updating the database of his/her ECRIN-supported projects
- Contributing to the development of tools facilitating multinational studies
- Contributing if required to the training of ECRIN European Correspondents and study staff
- Contributing to the development and maintenance of the quality management system, in particular as author/editor of SOPs
- Working on others duties as assigned
For tool development projects:
- Contributing to the work packages and task activities ECRIN is responsible for
- Ensuring that specific pieces of project work under the ECRIN responsibility are implemented and completed successfully in line with planned timelines
- Contributing to internal and external communication related to the projects
- Establishing strong interactions with the project partners
- Working on other duties as assigned
- University degree in Health or Life Sciences (PhD level would be a plus)
- Experience in multinational clinical research
- Experience in rare diseases clinical research
- Strong knowledge of the clinical research development process, GCP, local and international regulatory requirements.
- Complementary knowledge of experimental design, statistics and data management is desirable.
- Extensive experience in project management, in particular EU funded projects (H2020, IMI)
- Experience in operating at European/international level
- Excellent organisational skills, and ability in managing tasks across various functions and projects
- Strong oral and written communication skills
- Excellent written and spoken English (working language)
- Team player
- Computer and software knowledge
The post is under the responsibility of the Operations Director. The Project Manager shall work in close collaboration with the ECRIN Management Office in Paris and the national European Correspondents based in the ECRIN member/observer countries.
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.
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 (email@example.com).
Deadline to receive applications: 30 September 2018
Expected start date: November 2018
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