1 Primary Purpose and Overall Objective of the Job:
Contribute to the conduct of clinical trials carried out for registration purpose on new in-vitro diagnostic solutions developed by bioMérieux (reagent, instrument, software) or for regulatory compliance purpose on existing IVD solutions already on the market.
2 Main Accountabilities:
Carry out the experiments and tests required for clinical studies of simple to moderate complexity, while respecting the study protocol and its requirements, the timelines and all applicable Quality Assurance and Safety standards
Provide accurate, high quality test results and reliable data
Document and record all activities to ensure traceability and quality of the clinical studies conducted
Contribute to the preparation of clinical studies carried out on external sites in Europe by managing all logistical, administrative, operational and technical activities: ordering of materials, preparation of biological materials (samples and strain sets), shipments to external sites, tracking of supplies, management of instrument configurations and qualifications on site, follow-up of instrument calibration and maintenance
Participate in the maintenance and management of the Clinical Affairs laboratory in accordance with the applicable Quality Assurance and Safety standards
3 Typical Studies-Experience, Skills and Qualifications:
3.1 Studies-Experience:
2/3 years of higher education in Microbiology, Biology or Biochemistry
3.2 Skills and Qualifications:
Basic scientific knowledge and theoretical laboratory organizational skills
Thoroughness, ability to perform technical demanding tasks
Ability to work in a team and in interface with many other bioMérieux internal functions
Ability to provide and transfer accurate information
Ability to positively represent the laboratory and Clinical Affairs department
4 Scope and Resources Accountability, Typical Performance Indicators:
Scope and Resources Accountability: Technical, operational and logistical contribution to clinical studies; Activities performed under the supervision of lab manager or an experimented and skilled Clinical Affairs Technician (level 2 or 3)
Financial Indicators (revenue, budget, etc.): Not applicable
Key Performance Indicators (KPIs): Absence of major delays and of critical deviations impacting the quality of clinical studies Key Contacts (internal/external) and Interfaces: Collaborative work with all Clinical Affairs co-workers (CS, DM); Several interfaces with multiple bioMérieux internal functions (GCS, Subsidiaries, SES, Export, Warehouse, R&D, ...)
