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
Carry out the experiments and tests required as part of the validation of the instruments and their configurations in accordance with the study protocol and its requirements
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
Contribute to site visit and study set-up on external sites in Europe by providing technical training to site operators for instrument, reagent, testing and data management in accordance with the study protocol
Provide Level 1 support to external sites by managing complaints and technical problems observed during the conduct of clinical studies
Participate in the maintenance and management of the Clinical Affairs laboratory in accordance with the applicable Quality Assurance and Safety standards
Typical Studies-Experience, Skills and Qualifications:
Studies-Experience:
2/3 years of higher education in Microbiology, Biology or Biochemistry
Minimum 2 years of laboratory experience
Skills and Qualifications:
Scientific knowledge and advanced organizational skills (laboratory reference techniques, norms and standards for the conduct of experiments and tests) allowing an autonomous realization of technical tasks
Thoroughness, ability to perform complex and technical demanding tasks
Ability to work in a team and in interface with many other bioMérieux internal functions
Teaching skills to transfer technical knowledge to peers in Europe (training of operators on external sites)
Ability to positively represent the laboratory and Clinical Affairs department outside bioMérieux
Scope and Resources Accountability, Typical Performance Indicators:
Scope and Resources Accountability: accountable for technical, operational and logistical support to clinical trials within the scope of his/her perimeter
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, ...); Frequent interactions with peer functions within external sites in Europe
