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Microbiology Clinical Trial Scientist

BioMerieux Inc


Location:
St. Louis, Missouri 63042
Date:
01/05/2018
2018-01-052018-02-04
Job Type:
Employee
Categories:
  • Clinical Operations
BioMerieux Inc
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Job Details

Job Description:

The overall job responsibilities include but not limited to timely and accurately planning, initiation, execution and completion of clinical trials of clinical microbiology products (such as antimicrobial susceptibility testing including VITEK-AST and E-test products and microbial identification testing including VITEK-MS) for regulatory approvals.

The person participates in the project teams representing the Clinical Affairs group for the appropriate planning and execution of the clinical trial processes.

Microbiology Clinical Trial Scientist prepares clinical trials including participation in the selection and qualification of sites, contract negotiation, study design and writing trial plans and protocols; and set up, equip and training of sites. 

The person conducts data monitoring as appropriate; prepares and assembles final trial reports and data packages, maintains clinical trial files and documents for completeness; prepares and conducts technical reviews to launch and close trial. The person also appropriately supports in the audits as needed.

The additional responsibilities include but not limited to the  identification, participation and taking lead in the continuous improvement activities.

 

 Qualifications

 Requirements:

 Typical Studies-Experience, Skills and Qualifications

 Bachelor’s degree with 5 – 6 years relevant experience clinical lab or industry experience.  Preferably in Microbiology, Pharma or Clinical Trial Management.

 MS in a scientific field with clinical emphasis; minimum 3 years industry experience, 2 years of which in a clinical lab; (experience using IVD products and some clinical trials experience)

 Microbiology Experience preferred. (clinical microbiology or in  hospital lab setting).

 Required Clinical Microbiology Experience and/ or Clinical Trial Process.

 Negotiations and strong communication abilities required. 

 

Skills and Qualifications:

 

 Demonstrated written and oral communication skills in English;

 Problem Solving/Judgment/Analytical Thinking;

 Relationship Building/Teamwork and Collaboration;

 Innovation/Flexibility.

 

BioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity.

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