Valeant Pharmaceuticals

  • Clinical Data Coordinator

    Job Location US-NC-Raleigh
    Job ID
    10134
    Pos. Category
    R&D
    Pos. Type
    Full Time
  • Overview

    Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

     

    This position is responsible for supporting and coordinating data management activities on clinical studies.  This includes, but not limited to, reviewing Case Report Form (CRF) and Data Clarification Form (DCF) data according to study specific Data Management Plan (DMP) and Standard Operating Procedures (SOP) as well as study protocol.  Responsible for assisting in design, setup, and execution of study specific DMP.  This position provides assistance in the study database setup and validation.    

     

    This position will report to the Manager, Clinical Programs (Data Management) or higher.

     

    Responsibilities

    • Assist with development or review of study specific DMP, CRF/eCRF development, edit check specifications, and other data management documents.
    • Actively participate in study database setup and testing.
    • Support managing clinical study data through subject data reviews, data listings, identifying data discrepancies, verifying data query resolutions, reviewing medical coding, conducting SAE reconciliation, etc.
    • Generate data listings and ad hoc reports to assist in data review. 
    • Participate in process improvement discussions to improve department efficiency and productivity.
    • Support internal and external clinical study audits conducted by internal Quality group and/or by regulatory authorities.
    • Support development of data management standard operating procedures, guidelines, and conventions.

    Qualifications

    • Must have a minimum of 2 years of clinical data management experiences in a pharmaceutical, biotech or medical device industry. 
    • Must have a minimum of 2 years of clinical trial process including directives established by the FDA and ICH.  
    • Incumbent must be organized, attention to timeline and details, good communication skills (verbal and written), and able to work in the matrix environment.

    Be Aware of Recruiting Fraud

    Valeant is an EEO/AA employer M/F/D/V.

     

    Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

     

    To learn more please read Valeant’s Job Offer Fraud Statement.

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