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.
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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
- 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
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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
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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.
