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Study Director/Study Monitor

Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: August 12, 2019

Job Description:

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. Act as Study Director or Study Monitor for general toxicology studies conducted internally or at a Contract Research Organization (CRO), respectively. Responsible for ensuring the nonclinical studies assigned to her are conducted in compliance with approved study protocols, Standard Operating Procedures (SOPs), and, if appropriate, Good Laboratory Practice (GLP) regulations. As both Study Director and Study Monitor, collaborate with internal and external support groups including, but not limited to, DSE Management, DSE Project Representatives, Anatomic and Clinical Pathology staff, Veterinary Sciences staff, Discovery colleagues, and CRO Study Directors. Job Responsibilities:

  • Main focus of role will be to act as Study Director and Study Monitor for general toxicology studies conducted internally or at a Contract Research Organization (CRO), respectively
  • Ensure nonclinical studies are conducted in compliance with approved study protocols, Standard Operating Procedures (SOPs), and, if appropriate, Good Laboratory Practice (GLP) regulations
  • Ensure compliance with all company/departmental policies, as well as other federal, state and corporate policies and guidelines
  • Create an atmosphere of scientific excellence, open communication, and creativity in order to maximize productivity
  • Continuously evaluate and apply new scientific methodology in order to maintain scientific or technical excellence, to increase productivity, to meet our research and drug registration needs As Study Director for in-house nonclinical toxicology studies:
    • Collaborate with Biological Technicians and Study Supervisors; provide direction and encouragement in the performance of their job duties (as appropriate) during the conduct of nonclinical studies
    • Prepare and ensure compliance with study protocols
    • Monitor and manage daily study operations
    • Ensure the proper organization and recording of study data
    • Evaluate and interpret test results and prepare written summaries and reports in accordance with established timelines and which meet regulatory requirements
    • Keep DSE project representative and management apprised of study findings and results
    • Prepare and submit study data to the departmental archivist - As Study Monitor for studies that conducted at CROs:
      • Provide study design forms to CRO Study Director and ensure that final protocols are aligned with the approved study designs
      • Coordinate review of protocols, reports, and amendments thereof with key stakeholders within BMS
      • Periodically travel to CROs to ensure studies are being conducted in compliance with protocols, SOPs, and regulatory requirements
      • This will include observing critical study activities (e.g. first dose administration), reviewing training records of study staff, and reviewing study data
      • Maintain regular contact with CRO Study Director to ensure up-to-date knowledge of study status and findings
      • Keep DSE project representative and management apprised of study findings and results
      • Work with CRO Study Director to evaluate and interpret test results and ensure written summaries and reports are prepared in accordance with established timelines and which meet regulatory requirements
      • Communicate potential issues related to CRO performance to DSE management As both Study Director and Study Monitor, collaborate closely with internal and external support groups, including but not limited to staff in DSE Project Representatives, Pathology staff, analytical and bioanalytical laboratory staff, Veterinary Sciences staff, and Discovery colleagues
        • Ensure internal and external studies are conducted in compliance with current animal welfare standards
        • Embrace/demonstrate BMS Core Behaviors
        • Ensure good housekeeping and a safe work environment by enforcing departmental policies and procedures
        • Perform other tasks/procedures as assigned by line management Minimal knowledge base/skill set and position requirements:
          • BS, MS, or PhD in toxicology or related discipline with at least 3 years of experience in the conduct of toxicology studies required for the product registration
          • Position level will be commensurate with experience/qualifications
          • Knowledge of the general principles of toxicology, animal and human biology and physiology, especially clinical and functional changes associated with toxicity
          • Effective written and oral communication skills, especially as they pertain to writing clear and accurate toxicology reports
          • Ability to effectively communicate with co-workers at all levels and to work independently
          • Thorough knowledge of Standard Operating Procedures and Good Laboratory Practice Procedures
          • Knowledge of laboratory animal welfare standards (USDA, AALAC, etc.)
          • Role will involve 15-30% travel (US and Canada) Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Keywords: Bristol-Myers Squibb Company, New Brunswick , Study Director/Study Monitor, Executive , New Brunswick, New Jersey

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