The European Clinical Research Infrastructure Network (ECRIN, www.ecrin.org), a public research organisation, is currently recruiting a Quality Manager, to be based at its Paris head office.
ECRIN is a not-for-profit organisation, supporting clinical research across Europe.
ECRIN is connecting national clinical research networks (mainly academic clinical trial units (CTUs)), having the capacity to manage clinical trials on the national level. ECRIN provides information, consultations and operational clinical trial tasks and services to Sponsors and/or investigators of clinical trials initiated by academic investigators or SMEs.
ECRIN’s involvement covers all clinical trial activities, from study planning and preparation of grant application, to the set-up and conduct of multinational clinical trials in any disease area.
ECRIN is also developing tools, services to facilitate multinational clinical trials and is running a data centre certification programme which includes audits of the data centres.
You will be responsible for the implementation maintenance and upgrade of the Quality Management System and for the Data Centre Certification programme. You will work closely with our core team based in Paris and with our staff located in the various ECRIN member / observer countries.
Your responsibilities include:
Quality Management System
- Coordinate the development, implementation, maintenance and improvement of the ECRIN-ERIC quality management system and the quality documents
- Maintain the ISO 9001:2015 certification for the principal services
- Manage the follow up of risks, deviations and CAPA
- Propose actions to improve indicators evaluating the quality management system
- Participate in the development and delivery of quality training programmes as appropriate
- Contribute to the information and communication policy on quality management system
- Support the operational teams with the development of quality documents
- Liaise with the quality experts of the different ECRIN countries to maintain a thorough understanding of the national organisations and requirements
- Liaise with the quality managers of the other European research infrastructures to develop a consistent quality policy across infrastructures
Data management centre certification programme
- Ensure the secretariat of the programme and plan, coordinate and ensure actions follow up for the Certification Board.
- Maintain, develop and train the pool of auditors
- Maintain and develop the standards
- Maintain and develop the audit data base
- Conduct or lead audits of the data centres as appropriate
- Plan, coordinate, lead, conduct and report internal audits and external audits of the structures (in particular clinical trial units)/projects
- Ensure audit actions follow-up with the auditees
- Participate in projects as requested
- Provide support to staff as appropriate
- Undertake any ad hoc initiatives as required by the Directors
- University degree in Health or Life Sciences with experience or quality diploma/qualification
- Experience in multinational clinical research
- Experience in quality management
- Experience in leading/performing audits
- Experience in operating at European/international level and in multicultural environments
- Excellent organisational and time management skills, and ability in managing tasks across various functions and projects
- Strong oral and written communication skills
- Team player
- Excellent written and spoken English (working language)
- Computer and software knowledge
The post is under the responsibility of the Operations Director.
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) shall be addressed to Mrs Alicja Szofer-Araya (firstname.lastname@example.org), who may also be contacted for further details.
Deadline to receive applications: 15 February 2022
Expected start date: April 2022
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