STAFF CLINICAL STUDIES SCIENTIST - Beckman Coulter

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STAFF CLINICAL STUDIES SCIENTIST - Beckman Coulter

Job Requisition Number:  66037
 Site Location:  MIAMI 
 Job Title:  STAFF CLINICAL STUDIES SCIENTIST 
 Employment Status:  Full-Time 
 City:  Miami
 State/Province:  Florida 
 External Description: 
Staff Clinical Studies Scientist-66036

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Instruments for life science research are used by scientists as they study complex biological problems including the causes of disease, identify new therapies, and test new drugs. Our customers include hospitals, physicians' offices, diagnostic reference laboratories, pharmaceutical and biotechnology companies, universities, medical schools and research institutions. In fact, Beckman Coulter has more than 200,000 clinical and research instrument systems operating in laboratories around the world.

Job Description/Purpose of Position
Plans, organizes and monitors complex internal and external clinical studies for new or improved products. Prepares comprehensive clinical plans and protocol study designs to meet intended use of product. Works with Regulatory Affairs to define strategy for product FDA submissions and global regulatory registrations. Works with biostatistician to ensure statistical soundness of study design and appropriate data analyses. Identifies key centers for studies, identifies necessary resources and may negotiate clinical contracts.

Qualifications :

 

  • Experience in Flow Cytometry and Hematology, good understanding of the clinical applications in diagnostic flow or hematology particularly in the areas of hematolymphoid malignancies, immune monitoring and, infectious diseases. Understands unmet clinical needs of these users. Ph.D or MSc in immunology, Cell Biology or Biochemistry or B.S with relevant years of experience.

     

  • Knowledge of FDA requirements for product validation. Experience presenting study/testing rationale to FDA in Pre-IDE or PMA meetings a plus.

     

  • Experience with clinical study design to meet product intended use.

     

  • Good presentation and writing skills. Able to present to highly technical team or present summaries to upper management. Will interact with key opinion leaders and customers for clinical studies. May take leadership in preparing manuscripts resulting from evaluations for acceptance in peer-reviewed journal.

     

  • Knowledge of basic statistics for study design. Able to interact with biostatistician for design and data analyses.

     

  • Able to work in a cross-functional team and manage study timelines.

We’re Better Together

“We’re Better Together” –collaboration across all business centers and functions-fundamental to our success. You’ll join an established, profitable and highly successful global leader that has proven itself capable of evolving to meet the needs of the marketplace and maintaining a healthy growth rate throughout.

High impact & visibility- you’ll direct and control the sales, service and/or marketing organizations for a significant segment of the company's commercial operations.

Career Development-advancement opportunities and diverse career paths are trademarks of the Beckman Coulter experience, and as you master your accountabilities, you’ll be ideally positioned to evolve along multiple career paths.

Excellent benefits-in addition to a very competitive salary and bonus opportunity, we offer a robust benefits package that includes low cost health insurance coverage for you and your family; matching 401(k) as well as a retirement account plan; stock purchase options; paid time off (PTO) and holidays.

If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com.
 
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