Bausch Health

  • Clinical Trial Associate

    Job Location US-NJ-Bridgewater
    Job ID
    11037
    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.

    Responsibilities

    • Collaborates on and supports CTM on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection, Trial Master File structure and preparation, and communication with clinical trial sites regarding administrative documentation, support materials and training 
    • Supports CTM and clinical operations team to ensure compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all clinical investigations and post-market studies 
    • Supports CTM and clinical operations in communication with clinical trial sites regarding study conduct, monitoring, logistical management of follow-up and close out study visits to ensure compliance with protocols and GCP requirements 
    • Assists in tracking study specific payments 
    • Provides operational or work flow support to assure that departmental and cross functional systems and procedures are efficiently and correctly completed 
    • Collaborates on project teams, primarily with the Clinic, Research and Development, Advanced Development, Marketing, Regulatory and Quality/Compliance 
    • Supports CTM and clinical operations members with administrative documents related to all clinical study programs, TMFs, and study start up activities
    • Assists and supports CTM and clinical operations team in presentations of clinical information concerning specific projects 
    • Works on projects of moderate-to-high degree of difficulty in which analysis of situation or appropriate judgment and flexibility is required and should be exercised

     

    Qualifications

    • Bachelor’s degree in a health profession or science. Advanced degree a plus. 
    • At least 2 years of on-going clinical trials experience. 
    • Demonstrated proficiency in knowledge of GCPs and knowledge of FDA regulatory requirements. 
    • Knowledge of medical terminology. 
    • Ability to effectively work independently 
    • Excellent verbal and written communication skills plus computer proficiency (Word, Excel, Outlook). 
    • Travel may be required (minimal).


    Language and Verbal Skills 

    • Individual must have good verbal skills and written skills plus a demonstrated ability to communicate clearly and professionally.


    Analytical and Reading Skills 

    • Ability to read, analyze, interpret and assist in the creation and refinement of company procedures. Ability to assist in identifying problems, collecting data, draw valid conclusions, and report on findings.

     

    Physical Requirements

    • While performing the duties of this job the employee may be required to perform tasks involving lifting weights of up to 30 pounds for short durations. Duties of this job may involve standing and/or walking for extended periods of time. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision. Duties will also include air travel both domestically and internationally.

     

    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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