Biomerieux , Inc.
Microbiology Clinical Trial Scientist
At a glance
Location: US-MO-St. Louis, MO, United States Map
Posted: 09/17/2019
Closing: 10/16/2019
Degree: Graduate Degree
Type: Full-Time
Experience: 2 to 3 years
Biomerieux , Inc.
Job description
World leader in the field of in vitro diagnostics for over 55 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety. bioMérieux is present in 43 countries and more than 160 countries with the support of a large network of distributors. Its corporate headquarters are located in Marcy l'Etoile, near Lyon, in France. Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. We look for candidates whose motivation is to invest in themselves, in the projects of the future, and to participate in a collective adventure led by a pioneering spirit. We have the commitment to offer our collaborators a working environment which encourages team spirit, with priority given to training and development with international career opportunities.

A strong Scientific and technological pioneering spirit drives bioMérieux development since its creation in 1963. We design innovative in vitro diagnostic solutions for our customers that initiate new forms of scientific partnerships to be at the forefront of the most advanced technologies. Our presence in more than 150 countries with 9,400 employees worldwide secures bioMérieux commitment to public health. bioMérieux products are used to diagnose infectious diseases, they provide high medical value results for cancer screening and monitoring, cardiovascular emergencies and contamination to improve patient health and ensure consumer safety. Products also include industrial microbiological controls to detect microorganisms in food, pharmaceutical and cosmetic products. We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities. Job Description: He/she manages multiple clinical projects of an increasing complexity through design, preparation and conduct of clinical studies in multiple trial sites at a global level, which final deliverables correspond to the central piece of the regulatory submissions and approval processes. He/she balances between a highly regulated environment within project constraints to meet company objectives. He/she is consulted by others in technical decisions. Leads clinical projects by managing milestones and interfaces, as per quality/regulation, as well as timelines and costs prerequisites as negotiated with the project manager ahead of the trial. Pilots the CA element team compound of Data Management specialists, Internal lab rep, BioMaths and potentially teams of Clinical Scientists. May contribute to the management of CROs, particularly focused on the operational implementation. Will be exposed to competent and regulatory bodies (e.g. FDA...) for interactive submission reviews. Prepares clinical trials, including: developing trial strategies, designing studies and writing plans, writing protocols, identifying, selecting and qualifying sites, negotiating budgets and contracts in collaboration with purchasing department, setting up, equipping and training sites. Develops the monitoring strategy (monitoring plan) by collaboratively works with DM requisites for database building, data retrieval and review. Conducts and monitors clinical trials, coordinating all contacts with the sites, as well as building and maintaining relationships with investigators and the sites in connection with project team. Coordinates periodical data review and analysis, problem solving and troubleshooting. Leads preparation of final trial reports, maintains clinical trial files and audits for completeness. Prepares and leads technical reviews to launch and close trials. Prepares posters and publications, in collaboration with PI for manuscript. May present (poster or oral communication) in international congresses. Contributes to project as project team member representing Clinical Affairs; may significantly influence project decisions. Serves as internal technical reference in a field. He/she may assume other transversal Clinical Affairs related missions and pilots global (EU and US) functional excellence departmental activities. Leads preparation of final trial reports, maintains clinical trial files and audits for completeness. Prepares and leads technical reviews to launch and close trials. Prepares posters and publications, in collaboration with PI for manuscript. May present (poster or oral communication) in international congresses. Accountability: Endorse the full responsibility of the entire clinical trial process of global trials with complex protocols, including activities managed by other CA element team members (DM, Lab...) as well as activities managed by external partners (mainly clinical sites). Typical designs will involve: particular/rare diseases with low prevalence, significant number of sites, volume of data and interfaces to coordinate, new marker or new drugs, lab and patient's oriented trials...). Requires regular national or international trips for the purpose of site initiation, study monitoring and study close-outs. Requires specific technical knowledge and ability to negotiate with investigators/doctors and other internal interfaces. Provides guidance and advice to more junior level Clinical Scientists and Project Teams. Key Performance Indicators (KPIs): Successful completion of trials with low level of deviation from protocols; Successful problem solving with minimal consequences to project timelines or product success; Timely and accurate reporting of trial progress with no surprises to Project Team.

Requirements: Typical Studies-Experience, Skills and Qualifications * Master's Degree in a scientific field with clinical emphasis, and ideally, in methodology in biomedical research ; minimum 5 years of industry experience, of which 2 should be in IVD and 3 to 5 years' experience conducting clinical trials; * Or PhD with minimum 2 years of industry experience or post-doc with clinical exposure; * Technical skills in the corresponding area (trial design methodology, scientific field), project management oriented * Microbiology Experience preferred (Clinical microbiology or in hospital lab setting). * Fluent in English Skills and Qualifications: * Demonstrated written and oral communication skills in English; * Problem Solving/Judgment/Analytical Thinking; * Relationship Building/Teamwork and Collaboration; * Innovation/Flexibility. * Negotiations and strong communication abilities required. bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity.
Microbiology Clinical Trial Scientist