• Clinical Affairs Specialist

    Location CH-FR-Cressier
    Requisition ID
    2018-7374
    # of Openings
    1
    Category
    RA
  • Overview

    Bio-Rad is an innovative company and thanks to its laboratory diagnostic systems world leader in the field of blood group serology.

     
    Our company is involved in the supply of high-quality products and services intended for diagnostic laboratories. Independence, innovation and commitment are the fundamental values that permeate our company culture, as well as a strong orientation towards our customers and a multicultural environment.

     

    Bio-Rad in Cressier/Switzerland is looking for a Clinical Affairs Specialist 100%.

    Responsibilities

    • You coordinate tasks to implement clinical trials; plan, organize, instruct, troubleshoot and monitor clinical trials according to approved protocols to ensure that study objectives are achieved.
    • You prepare/revise study designs, protocols, and protocol addendums.
    • You review analytical and clinical data, recognize inconsistencies, and initiate the resolution of data problems.
    • You ensure the accuracy and integrity of analytical and clinical data. You provide data analysis reports and line listings to support product performance measurements for presentation in EU and WW regulatory submissions.
    • You ensure the accurate and consistent handling of analytical and clinical data, and ensure that data management tasks are conducted according to Good Clinical Data Management practices.
    • You coordinate with Clinical Research Associates to develop clinical evidence processes, work instructions and associated forms.
    • You participate in the design and performance of pre-clinical studies of new products to ensure that specifications are met.
    • You write the product performance evaluation report as well as the "performance and use limit" section of the instructions for uses and sustain the clinical evidence file taking into account data collected post-market.

    Qualifications

    • You hold a scientific university degree or an engineer diploma in biology, biochemistry, immunology or pharmacology.
    • You have at least 2 years of professional experience in the field of diagnostics or biotechnology.
    • Experience in immuno-hematology is an asset.
    • You have a proactive nature and a strong customer-orientation.
    • You are native French or German with good knowledge of the other language and you also have a very good command of spoken and written English.

    Do you see your next professional challenge in this position? We look forward to receiving your application. If you click on "Apply", you have the option of submitting your complete cover letter, resume and credentials in a coherent PDF or Word document.

     

    To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

     

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